Clinical Research Directory

Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer .

Primary Objectives * In phase 1b cohort, to determine MTD (maximum tolerated dose) of nal-IRI (ONIVYDE®) in combination with Ramucirumab (Cyramza®) and TAS-102 (LONSURF®) * In phase II cohort, to evaluate disease objective response rate (ORR) of Ramucirumab (Cyramza®), nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®) Secondary Objectives * To evaluate disease control rate (DCR) * To evaluate progression-free survival (PFS) * To evaluate overall survival (OS) * To assess the safety profile * To study the blood biomarkers

Comparing the Effects of Art Therapy and Mandala Application on State Anxiety Levels in Chemotherapy Patients

The research is planned as a randomized controlled trial with a two-group (art-based flow drawing and mandala), pre-test, post-test design.

Digital Media Use and Treatment Adherence in Chemotherapy Patients

This study aims to examine the relationship between digital media use and treatment adherence in patients receiving chemotherapy. Digital media has become an important tool for accessing health information, participating in support networks, and managing treatment processes. However, the extent to which digital media use affects treatment adherence in oncology patients remains unclear. This observational study will be conducted with adult patients receiving chemotherapy in an outpatient setting. Data will be collected using a sociodemographic information form, the eHealth Literacy Scale (eHEALS), and treatment adherence measures. The findings of this study are expected to contribute to understanding how digital media use influences treatment adherence and may help guide interventions to improve adherence in cancer care.

ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer

In the case of primary surgery, in patients with sentinel node involvement, it has already been shown that omitting axillary lymph node dissection (ALND), often combining axillary radiotherapy (RT), does not worsen the prognosis and does significantly reduce the appearance of lymphedema. However, patients who have received neoadjuvant systemic treatment cannot benefit from this option, even though in the majority of those who have responded well to treatment, a residual disease in the armpit is low, but there are no studies yet published that supports the possibility of not performing lymphadenectomy. The primary endpoint is to evaluate wether axillary radiotherapy (ART) presents a lower risk of lymphedema with respect to lymphadenectomy (ALND) in patients with breast cancer who, after neoadjuvant systemic treatment (NST), present the sentinel node affected. Likewise, we will evaluate recurrences and overall survival in both groups. Finally, we will analyze the quality of life of these patients.

Efficacy of the MAEva Program (Meditation, Acceptance, and Commitment to Values) in Breast Cancer Patients Undergoing Chemotherapy

The MAEva program combines Acceptance and Committment Therapy (ACT) and mindfulness practices. It is an open and circular intervention, in three sessions (Mindfulness, Acceptance, and Commitment to values). It is designed for cancer patients and was the subject of an initial study that explored its feasibility and acceptability, as well as the initial results on psychological well-being. This randomized, multicenter clinical trial is necessary to demonstrate the efficacy of the MAEva program compared to a discussion group with non metastatic breast cancer patients undergoing chemotherapy. Patients will be included and randomized into two arms: * In the first arm, patients will have the opportunity to participate in the MAEva program for nine consecutive weeks. * and the second arm patients will have the opportunity to participate in a discussion group for nine consecutive weeks. The patients will be able to attend one session per week for nine consecutive weeks. Quantitative assessments of quality of life, symptoms of stress, anxiety, and depression, as well as psychological flexibility, will be conducted before the first session, after 3 weeks, 9 weeks, and 12 weeks. Also, a qualitative analysis will be conducted based on satisfaction questionnaire and a semistructured interview performed after the end of the program. The interview analysis will described the extent to which the intervention is adapted to the realities on the ground and the needs of the target population. It will enable to identify how patients appropriate the psychological flexibility processes taught in the program in relation to the conceptual framework of ACT therapy (i.e., contact with the present moment, self-as-context, acceptance, defusion, values, and committed action) and integrate them into their daily lives.

Receptive Music Therapy Effects on Anxiety, Depression, QoL, and EGF, IL-8, and NfL During the Breast Cancer Treatment.

The goal of this clinical study is to investigate whether receptive music therapy can help women with breast cancer by reducing anxiety and depression symptoms, improving quality of life, and influencing specific analytes in plasma, including epidermal growth factor (EGF), interleukin-8 (IL-8), and neurofilament light chain (NfL). Main Questions the Study Aims to Answer: GENERAL OBJECTIVE: To investigate the effect of receptive music therapy on anxiety and depression symptoms, quality of life, and the levels of epidermal growth factor, interleukin-8, and neurofilament light chain in plasma during treatment in women with breast cancer. SPECIFIC OBJECTIVES: * To determine whether there is a correlation between the levels of epidermal growth factor, interleukin-8, and neurofilament light chain in plasma and the severity of anxiety and depression symptoms. * To determine whether there is a correlation between the severity of anxiety and depression symptoms and quality of life. Participants will be randomly assigned to either a music group or a control group. The study will take place during the perioperative period and chemotherapy (in participants for whom chemotherapy will be indicated). At two (perioperative) or three (+ chemotherapy) time points, participants will: * Undergo assessments for anxiety, depression, and quality of life * Provide blood samples for analytes analysis (EGF, IL-8, NfL) * Receive music therapy sessions (for those in the intervention group) The scientific contribution of this study lies in understanding the relationship between the application of receptive music therapy and the plasma levels of epidermal growth factor, interleukin-8, and neurofilament light chain in women with breast cancer during the perioperative period and chemotherapy, as well as its association with the occurrence of pronounced anxiety and depression symptoms related to the malignant process. This study represents the first application of such research in this patient population and serves as a foundation for the future implementation of receptive music therapy in the complementary treatment of breast cancer.

IC Plus Low-dose Radiation Plus Cadonilimab in LANPC

This is a multi-center, open-label, randomized controlled phase III clinical trial in primary diagnosed loco-regionally advanced nasopharyngeal carcinoma (NPC) patients. The purpose of this study is to evaluate the efficacy of induction chemotherapy (IC) combined with low-dose radiation and immune checkpoint inhibitor (ICI) followed by concurrent chemoradiotherapy (CCRT) versus IC+CCRT, and compare the treatment-related adverse events and quality of life in two groups.

Ponatinib Plus Chemotherapy in Acute Lymphoblastic Leukemia Patients

Acute lymphoblastic leukemia (ALL) is the most frequent cancer in children, decreases in adolescence and adulthood, and a second peak can be recorded starting from the 6th decade of life. While the outcome in children is excellent, in the adolescent/adult population, the prognosis, though improved over the decades, it is still unsatisfactory and novel biologically-driven approaches are urgently needed. In this setting, thanks to the introduction of genome wide technologies, it was possible to recognize specific subset of ALL. Among those, the BCR/ABL1-like ALL are of extreme importance, since they are characterized by an unfavourable outcome and, on the other hand, can benefit of a targeted treatment, in particular with the pan-tyrosine kinase inhibitor ponatinib. The primary objective is to evaluate the clinical response - in terms of MRD negativity - in patients with a BCR/ABL1-like profile, according to the BCR/ABL1-like predictor tool, treated with Ponatinib in combination with chemotherapy.

Measuring Fluid Buildup in Cancer Patients

The goal of this study is to improve the monitoring of fluid retention in cancer patients. The main question it aims to answer is: Can segmental bioelectrical impedance analysis be used to monitor local fluid retention (edema) in cancer patients? We will include: * Breast cancer patients with fluid and or lymph retention in one or both arms after radiotherapy (outpatients) * Cancer patients with fluid retention in one or both legs after chemotherapy (hospitalized) Participants will: * Have measurements taken using bioelectrical impedance * Provide blood samples and 24-hour urine collection * Weight monitorering * Complete diet and fluid registration (inclusive enteral and parenteral) * Have clinical palpatory and measurement assessment of oedema.

Home Monitoring of Complete Blood Count Performed by Patients - a Pilot Study on the Implementation Process in South Baltic Countries.

Introduction: The number of diagnosed cancers is systematically increasing every year. Cancer patients need to undergo regular blood tests to monitor safety and eligibility for treatment. In case of poor blood results, the chemotherapy session must be omitted. For patients living far from the center, this means unnecessary travel with involvement of helpers, additional costs, increased potential of hospital acquired infections, and frustration associated with missed opportunity for treatment. Aims: The primary aim of this study is to gain knowledge about successful implementation of remote, home monitoring of complete blood count to cancer patients during and after systemic treatment for cancer. The secondary aim of the AMBeR collective study protocol is to pilot new technology, gain more context around future investigations and verify costs and changes in patient treatment pathways. Methodology: The investigators will test implementation of home blood monitoring in three South Baltic Countries (DK, PL, GER). Each site will participate in the implementation study with study group á n=33 (total n=165) and control group n=20 (total n=100). The duration of the study is planned for 4 cycles of chemotherapy for each patient and a 3-month follow up period. The first cycle of learning and training at the Outpatient Daily Clinic, then the remaining 3 cycles of blood monitoring at home. The average cycle length is 21-30 days, number of measurements will be determined individually depending on the diagnosis. At a baseline, after 4 cycles of chemotherapy (12-16 weeks) and after a 3-month follow-up period, parallel studies will be carried out in both the study and control groups, using mixed methods the investigators will assess outcomes of reach, effectiveness, adoption, implementation and maintenance (RE-AIM). Expected benefits: Implementation of the AMBeR study should reduce the amount of unnecessary and nontherapeutic hospital visits and improve manageability and independence of the patients. The investigators believe that the decrease in the number of hospital visits will diminish the risk of infection for vulnerable individuals, as well as save costs for patients and hospitals. These factors will also translate into better logistics of chemotherapy units, decreased carbon-dioxide trail, and improved quality of life and patient empowerment.

Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study.

Systemic chemotherapy with or without palliative radiation represents the current standard of care in patients with recurrent or metastatic cervix cancer. In addition, pelvic radiotherapy including brachytherapy is also recommended. There is no consensus on the treatment of metastatic site in patients with oligo-metastatic or oligo-recurrent cervix cancer. Also, it is not clear if addition of local treatment to systemic chemotherapy benefits all patients with metastatic disease or a select few with limited systemic disease burden. It's presently unclear which patients derive maximum benefit with integration of radiation at both primary and metastatic site, who develop infield recurrence if performing salvage surgery, locally directed treatments or re-irradiation in addition to systemic chemotherapy improves overall outcomes. The heterogeneity in clinical practice provides an important opportunity to develop a framework for data collection and future studies within such subgroup of patients. In this retrospective study, we aim to determine overall survival, Infield progression free survival, overall progression free survival, dose response relationship of nodal and visceral progressions, and within setting of re-irradiation (infield progressions), severe adverse events and toxicity, risk groups identification, a nomogram which correlates risk groups with expected outcomes, and framework for tissue collection for translational research Investigators will record the parameters in a predesigned proforma without including personal identifiers.

Study on the Impact of Electroacupuncture Combined With Self-Acupressure on the Quality of Life of Patients With Early-Stage Breast Cancer Undergoing Chemotherapy

This randomized controlled clinical trial aims to evaluate the effect of electroacupuncture combined with self-acupressure on the quality of life of early-stage breast cancer patients receiving chemotherapy.

Feasibility and Acceptability of the Remote Oncology Symptom Assessment Application

The goal of this study is to determine whether a mobile application that combines real-time sensor data and patient-reported symptoms to trigger care-team contact recommendations is feasible and beneficial for patients receiving chemotherapy. The main questions it aims to answer are: * Is the mobile application feasible and acceptable to patients? * Do the alerts and guidance improve symptom management, quality of life, and engagement with the care team during treatment? Participants will: * Complete a demographic questionnaire at the beginning of the study and quality-of-life and health questionnaires at the beginning, midpoint, and end of study. * Complete daily symptom ratings. * Wear a Fitbit activity tracker for 90 days. * At the end of the study, complete a semi-structured interview to provide feedback on the study. * Optional: At the beginning and end of the study, complete an in-person physical function assessment measuring balance (Short Physical Performance Battery).

Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Locally-advanced Esophageal Squamous Cell Cancer (RICE)

This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of non-operative Locally Advanced Esophageal Cancer . The purpose of this study was to evaluate the efficacy and safety of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer.

Comparing of Sesame Oil, Nitroglycerin Ointment, and Aloe Vera Gel

compare the effectiveness sesame oil, aloe Vera gel, and nitroglycerin ointment prevention of phlebitis.

Resilience Enhancement Using Electronic Frailty Index-Directed Care Pathway

The study purpose is to gain a better understanding of the needs of adults aged 65 and older while they are receiving chemotherapy by measuring their resilience and tailor care plans based on their individual needs.

Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy

No predictive factors are known for the response to the bevacizumab anti-angiogenic molecule (Avastin) given in the event of relapse of glioblastoma (GBM) following radiochemotherapy. Classical MRI with gadolinium injection and perfusion is not sufficient to predict survival and response or duration. We propose to evaluate the prognostic interest for 6-month survival of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism recorded at 7 and 28 days of application of the treatment. These biomarkers are based on the increase of an index combining choline / Creatine (Cho / Cr), Glx / Cr (Glutamine and glutamate / Creatine), NAA / Cr (N acetyl aspartate / Creatine) and lactate / Cr ratios. The long-term objective is to predict the survival of these relapsed GBM patients at an early stage and to identify responder patients who would benefit from this expensive molecule and avoid using it in non-responding patients

Chemo Brain Prehab Project

Colorectal cancer is 37% higher in the North West than the national average and is treated by chemotherapy, including fluorouracil, capecitabine, and oxaliplatin. A side effect of these drugs is loss of memory, forgetfulness, and general brain fog, which can persist for months after the end of treatment. These symptoms are collectively known as 'chemo-brain'. An existing prehabilitation intervention that has been previously developed will be used, which increases fitness and reduces hospital length of stay in colorectal cancer surgery patients, to try to improve the symptoms of chemo-brain in those undergoing chemotherapy and improve quality of life.

Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable/Unresectable Esophageal Squamous Cell Carcinoma

Esophageal cancer (EC) ranks among the leading malignant gastrointestinal tumors globally in terms of both incidence and mortality. Cases of EC in China account for over 50% of the global total, with squamous cell carcinoma being the primary pathological type. Locally advanced EC (LAEC), particularly cases where radical surgical resection is not feasible, exhibits high recurrence rates and low 5-year survival rates. However, studies have shown that patients with LAEC who undergo comprehensive treatment followed by surgery experience significantly prolonged survival and improved quality of life compared to those who do not receive surgical intervention. Current conversion treatment regimens under investigation include: chemotherapy alone, chemoradiotherapy, immunotherapy combined with chemotherapy, and immunotherapy combined with chemoradiotherapy-each of these approaches has distinct advantages and limitations. Immunochemotherapy has emerged as a current research focus: it not only demonstrates significantly superior efficacy compared to chemotherapy alone but also exhibits lower cumulative toxicity than radiotherapy-combined conversion regimens, resulting in a more favorable overall benefit-risk ratio. As such, it represents the most promising conversion treatment strategy. Retrospective and prospective clinical studies have shown that low-dose radiotherapy targeting the small intestine can enhance the anti-tumor response of immune checkpoint inhibitors (ICIs) in patients with advanced solid tumor, prolong their overall survival, and increase the incidence of the abscopal effect. Further mechanistic investigations have revealed that intestinal low-dose radiotherapy (ILDR) may augment the immune cancerous lethality by modulating the gut microbiota and their metabolic profiles. Based on the findings from these preliminary studies, the current research plans to conduct a prospective phase II single-arm clinical trial to investigate the efficacy and safety of ILDR combined with immunochemotherapy as conversion therapy in patients with borderline resectable or unresectable esophageal squamous cell carcinoma (BR/UR ESCC). This research plans to enroll at least 39 evaluable cases or a total of 43 cases in two seperated stages, focusing on patients with thoracic BR/UR ESCC. Patients will receive a single fraction of ILDR with a mean dose of 1 Gy, concurrently with 3 cycles of albumin-bound paclitaxel (260 mg/m² on day 1), cisplatin (75 mg/m² on day 1), and tislelizumab (200 mg on day 1). The efficacy and safety of the treatment will be evaluated throughout the study.

Clinical Study of Acupoint Application on Relieving qi Deficiency and Constipation in Patients Undergoing Chemotherapy

4.1 Research Content 1. Clarifying the acupoint application scheme for deficiency and constipation in CRC patients undergoing chemotherapy: the preliminary acupoint application scheme for deficiency and constipation in CRC patients was formulated according to the systematic literature search, analysis of acupoint and traditional Chinese medicine prescription, analysis of meridian tropism of acupoints, Chinese herbal medicine taste and meridian tropism, etc., and multidisciplinary expert consultation. Through two rounds of Delphi expert letter consultation, the acupoint application scheme for deficiency and secret of CRC patients undergoing chemotherapy was determined. 2. Randomized controlled trials were conducted to compare the effect of acupoint application scheme and conventional treatment in improving constipation symptoms, total clinical efficacy, and improving patient comfort rate in CRC patients undergoing chemotherapy. 4.2 Key problems to be solved Based on the theory of "state-target dialectics", the analysis of acupoints and traditional Chinese medicine prescriptions, the analysis of meridian tropism of acupoints, the flavor and meridian tropism of Chinese herbs are used to select Chinese herbs that moisten the intestine and relieve defecation, strengthen the central and qi, and explore the acupoint application to provide a basis for more effective application of acupoint application in the treatment of qi deficiency and constipation in patients with CRC chemotherapy, form a generalized integrated Chinese and western medicine diagnosis and treatment plan, and promote the development of integrated Chinese and western medicine. 4.3 Expected Goals 1. Clarify the diagnosis and treatment plan of acupoint application in the treatment of qi deficiency and constipation in patients with colorectal cancer. 2. The flexible application of classic formula and scientific acupoint selection and sticking can effectively relieve qi deficiency and constipation in CRC patients undergoing chemotherapy, improve the total clinical efficacy and comfort of patients. It has been used in clinical practice and promoted to other medical institutions.

Physical Activity in Cancer Patients in an Oncology Day Clinic - Implementing a Person-centered Program Led by Nurses

Background: Physical activity has demonstrated benefits in alleviating side effects and improving well-being in people with cancer. However, activity levels remain low during systemic treatment. Nurses are optimally positioned to lead interventions fostering an activity-friendly culture. Objective: This study aims to evaluate the feasibility and potential effects of the nurse-led, interprofessionally developed physical activity concept OncoMoveNurse in an outpatient oncology setting. Methods: Using a mixed-methods design over 15 months (10/2024-12/2025), the study includes implementation and evaluation phases. Quantitative data (n=50 patients, collected from 06/2025-09/2025) will assess primary (physical activity behavior) and secondary outcomes (self-efficacy, well-being, mood) via validated PROMs. Qualitative insights will be gathered through digital storytelling (n=2 patients, n=2 nurses) and one focus group (n=8 interprofessional team members). Inclusion criteria for patients include age ≥18, cancer diagnosis, at least three treatments in the day clinic, and sufficient German language skills. Intervention: OncoMoveNurse comprises five adaptable components: modular activity structure, safety framework, communication strategy, a team approach, and person-centered orientation. Supporting materials (e.g., posters, videos, exercise tools) and tailored implementation strategies were co-developed in alignment with core values. Analysis: Quantitative data will be analyzed using SPSS (paired t-tests, p\<.05); qualitative data via content analysis in MAXQDA. A mixed-methods synthesis will integrate findings. Ethics \& Data Protection: Patient data collection will commence following ethics approval. All data are anonymized, stored securely, and handled in accordance with Swiss data protection laws. Conclusion: This study will provide insights into the feasibility of nurse-led physical activity promotion in outpatient oncology and inform future outcome evaluations.

A Phase 2 Randomized, Controlled Trial of QL1706 Plus Chemotherapy and Quad Shot for Driver Gene-negative Advanced Non-small Cell Lung Cancer.

Chemotherapy combined with immunotherapy has become the first-line standard treatment regimen for metastatic non-small cell lung cancer (NSCLC). QL1706 is an antibody that can simultaneously block the CTLA-4 and PD-1. In a phase II clinical study, when QL1706 was combined with chemotherapy for first-line treatment of metastatic NSCLC, the median progression-free survival (mPFS) was 6.8 months and the objective response rate (ORR) was 45% at a median follow-up time of 12.6 months (range, 0.4-15.2 months). Radiotherapy is one of the commonly used local treatment modalities for tumors, which has a synergistic effect with immunotherapy, can enhance the response to immunotherapy, and trigger the abscopal effect. Quad shot radiotherapy is a periodic pulsed hypofractionated radiotherapy, with a specific mode as follows: 2 fractions per day, with an interval of more than 6 hours between the two fractions, for 2 consecutive days, with a total dose of 14-14.8 Gy. This regimen can be repeated every 3-4 weeks for a total of 3 cycles, with a total treatment dose of approximately 44-48 Gy, and it can be used for palliative treatment of various advanced tumors. This project intends to explore whether the addition of Quad shot radiotherapy to QL1706 combined with chemotherapy can improve local and systemic tumor control rates, prolong patients' PFS, and evaluate the safety of the combined therapy in treatment-naive patients with metastatic NSCLC.

Applying the ADDIE Model to Develop a Multimedia Program to Enhance Chemotherapy Knowledge and Self-Efficacy Among Intensive Care Unit Nurses

Research Methods, Procedures, and Participant Requirements: This study will test a multimedia interactive learning system designed to help nurses conveniently learn about chemotherapy drug administration. The study is scheduled to be conducted from November to December, 2025. Participants are expected to cooperate with the following procedures: Pre-test: Complete a questionnaire that includes basic demographic information and a self-efficacy scale. The estimated time for completion is about 10 minutes. System Experience: Use the multimedia learning system developed by the research team to study topics such as chemotherapy administration procedures, common error management, and side effect monitoring. The total learning time is approximately 30 minutes, and participants may use the system at their own pace-continuous use in one session is not required. Post-test: After completing the learning session, participants will fill out another questionnaire assessing learning outcomes, changes in self-efficacy, user experience, and system usability. This takes approximately 15-20 minutes. The total participation time is estimated to be 45-60 minutes. All responses will be collected anonymously. Participants may contact the research team at any time if they have questions or concerns, and assistance will be provided as needed.

Mandala Painting During Chemotherapy

In addition to managing drug side effects that arise during cancer treatment, maintaining the patient's psychosocial well-being is also very important. Therefore, the aim of this project is to examine the effect of mandala painting during chemotherapy on anxiety, nausea, and comfort levels. This project aims to reduce the negative effects of chemotherapy, such as nausea, anxiety, and decreased comfort, by distracting the patient's attention through the non-invasive and non-pharmacological practice of mandala coloring in patients undergoing chemotherapy. Mandala painting is a distraction and positive focus practice. A limited number of studies conducted on cancer patients have shown that it reduces distress and improves psychological well-being. However, no study in the literature has comprehensively addressed the symptoms experienced by patients during chemotherapy, such as anxiety, nausea, intense stress, and impaired comfort. The research will be conducted on patients undergoing chemotherapy for the first time, and patients in the experimental group will engage in mandala coloring for at least 30 minutes. Data obtained from assessments conducted before and after chemotherapy will be compared with control group data. This project will provide a more comprehensive assessment of the effect of mandala painting, a non-pharmacological intervention, on the negative symptoms of patients undergoing chemotherapy for the first time. In addition to its scientific contribution, it is believed that effective symptom management can contribute to patients' well-being. Furthermore, if nausea can be controlled, the need for antiemetics during treatment can be reduced. This will also contribute to reducing unwanted drug effects and lowering costs.