Clinical Research Directory

Tumor Microenvironment in Gastric Cancer Patients Treated With Combined Immunotherapy and Chemotherapy

The goal of this study is to analyze the tumor microenvironment (TME) in gastric cancer patients treated with combined immunotherapy and chemotherapy. The main questions it aims to answer are: * Provide profiles of TME between pre-treatment and post-treatment to gain insights into the mechanisms of immunotherapy combined with chemotherapy in advanced gastric cancer * Investigate the crucial factors affecting treatment efficacy by comparing gastric cancer patients with varying treatment responses

Biomarkers in Multiple Myeloma

The association between multiple myeloma (MM) and venous thromboembolism (VTE) is well known. Indeed, the incidence of VTE is increased in patients with newly diagnosed MM and in patients treated by immunomodulatory drugs in combination with glucocorticoids. Moreover, the clinical outcome of MM is supposed to be correlated to the risk of thrombosis. At the biological level, a number of hemostasis abnormalities participate in increasing VTE incidence. Yet, data on predictive biomarkers linked to VTE are limited.

A Prospective, Biomarker-Stratified Phase 2 Study: β-Hydroxybutyrate as a Predictive Biomarker for Short-Course Radiotherapy Followed by Chemotherapy Plus PD-1 Inhibitor Versus Chemotherapy Alone in Locally Advanced Rectal Cancer

This is a prospective, single-arm, biomarker-stratified, multicenter phase 2 clinical trial. All enrolled patients first receive short-course radiotherapy (SCRT), followed by measurement of serum β-hydroxybutyrate (β-HB) levels to calculate the post-radiotherapy elevation rate. Patients are stratified into an β-HB-positive stratum (elevation significantly) and an β-HB-negative stratum (no elevation), then randomized 1:1 within each stratum to receive either perioperative chemotherapy plus PD-1 inhibitor or perioperative chemotherapy alone. The primary endpoint is the complete response (CR) rate, defined as the composite of pathological complete response (pCR) and clinical complete response (cCR). The study aims to evaluate the efficacy and safety of adding PD-1 inhibitor to perioperative chemotherapy in LARC, and to validate post-radiotherapy β-HB elevation as a predictive biomarker for immunotherapy benefit.

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 39 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.

The Effect of the 4-7-8 Breathing Technique on Anxiety, Symptom Burden, and Sleep Quality During Chemotherapy

This study aims to determine the effects of the 4-7-8 breathing technique on anxiety, symptom severity, and sleep quality during treatment. A randomized controlled trial design was employed, involving 64 participants (intervention group: n=32; control group: n=32) undergoing their third treatment cycle. The intervention group received the 4-7-8 breathing technique twice daily for 21 days in addition to routine care, while the control group received routine care and standard supportive care. Data will be collected at pre-test and post-test stages using the Descriptive Information Form, the State-Trait Anxiety Inventory (STAI-State), the Edmonton Symptom Assessment System (ESAS), and the Pittsburgh Sleep Quality Index (PSQI). Data analysis will be performed using the SPSS 22.0 software.

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.

Effect of Gamified Sun Protection Education Provided to Chemotherapy Patients

Chemotherapy may cause photosensitivity and other skin reactions that can negatively affect patients' comfort, quality of life, and adherence to treatment. Appropriate sun protection behaviors are therefore important for patients receiving chemotherapy. This randomized controlled trial aims to evaluate the effect of gamified sun protection education on sun protection self-efficacy and sun protection behaviors in patients receiving chemotherapy. A total of 54 patients will be randomly assigned to two groups, with 27 participants in each group. Participants in the intervention group will receive gamified sun protection education, while participants in the control group will receive usual care. The educational intervention will be delivered over a two-week period. Sun protection self-efficacy and sun protection behaviors will be assessed at baseline and after completion of the two-week intervention.

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.

Application of MRI Radiomics Features in Neoadjuvant Therapy of Head and Neck Squamous Cell Carcinoma

Head and neck squamous cell carcinoma is the sixth most common malignant tumor in the world. Neoadjuvant therapy, including neoadjuvant chemotherapy and immunotherapy, is recommended for patients with locally advanced head and neck cancer. The response to neoadjuvant therapy varies among the patients. It is reported that about 37% of the patients achieve pathological complete response after receiving neoadjuvant therapy, who would achieve a better prognosis compared with the patients with non-pathological complete response. It is significant to predict and assess response to neoadjuvant therapy for the patients with head and neck cancer accurately, which could assist in formulating individualized therapeutic regimens. MRI has good soft tissue resolution and is a common preoperative examination method. However, this method lacks the ability to accurately predict the probability of patients achieving pathological remission after neoadjuvant therapy. At present, it is a novel and effective method to construct a model to predict the efficacy of neoadjuvant therapy based on MRI image omics analysis, and certain achievements have been made in breast cancer and rectal cancer. In this study, multi-sequence MRI was combined with clinical risk factors to construct an imaging omics model to predict the probability of pathological complete remission of patients with head and neck squamous cell carcinoma after neoadjuvant therapy, and to accurately identify diagnostic imaging remission, so as to better assist clinical decision-making.

RegisterPROS - A Registry for Prostate Cancers

Prostate cancers are derived from epithelial cells in the prostate gland. Treatment options include surgery, medical (androgen signaling targeted and chemotherapy) and radiation therapy including radioligand therapy (RLT). Survival is linked to early and accurate diagnoses or to the effective detection of disease recurrence and/or treatment failure. One challenge is to develop accurate non-invasive tests that can detect prostate cancer disease activity. A second challenge is to evaluate the effectiveness of such biomarkers during the natural history of this disease (e.g., active surveillance). A third aim is to identify whether molecular markers can predict response to different therapies (either pre-treatment, or early on during the first few cycles of a therapy). RegisterPROS registry aims at collecting data and blood samples from patients being evaluated for PCa disease. Data will be entered prospectively and anonymized after informed consent. All physicians who treat PCas are invited to participate to the registry. Data will be evaluated within regular time frames, focusing on diagnostic accuracy for biomarkers in the different types of tumors, treatment modalities and patient outcomes (e.g. disease recurrence and survival), thereby contributing to an understanding of the role of biomarkers in tumor management.

Adjuvant Chemotherapy for High Malignant Prostate Cancer

This study aims to evaluate the efficacy of adjuvant docetaxel chemotherapy following radical radiotherapy in patients with localized high-grade prostate cancer. Eligible participants include those diagnosed with prostate cancer confirmed by biopsy or surgical pathology, with a Gleason score of 9-10 or containing a Gleason 5 component, and no evidence of distant metastasis. Patients will be divided into two groups: the standard treatment group receiving only radical treatment (radiotherapy or surgery), and the standard treatment plus chemotherapy group, receiving four to six cycles of docetaxel chemotherapy after standard treatment. The primary endpoint is Failure-Free Survival (FFS), with secondary endpoints including Biochemical Relapse-Free Survival (BRFS), Metastasis-Free Survival (MFS), Overall Survival (OS), and assessment of adverse events The study aims to better understand the impact of adjuvant chemotherapy on the prognosis of patients with high-risk prostate cancer and determine whether it improves survival outcomes.

Assessment of Adebelizumab Combined With Chemotherapy in Concurrent Radiotherapy Versus Sequential Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

Immunotherapy combined with chemotherapy has emerged as the standard of care for patients with extensive-stage small cell lung cancer (ES-SCLC). The incorporation of thoracic radiotherapy can enhance treatment efficacy. Currently, the main types of research investigating immunotherapy combined with thoracic radiotherapy for untreated ES-SCLC are concurrent radiotherapy and sequential radiotherapy. The aim of this study is to evaluate the efficacy of adebelizumab in combination with chemotherapy, when administered concurrently with radiotherapy versus sequentially with radiotherapy, as a first-line treatment for ES-SCLC.

Aromatherapy Combined With Standard Antiemetic Therapy vs Standard Therapy Alone for Prevention of CINV in Breast Cancer Patients Receiving Highly Emetogenic Chemotherapy

This phase III, multicenter, randomized, open-label trial evaluates whether aromatherapy plus standard antiemetic therapy improves complete response (CR) of CINV compared with standard therapy alone in breast cancer patients receiving highly emetogenic chemotherapy (HEC). Despite guideline-recommended triple prophylaxis (5-HT3 antagonist, NK-1 antagonist, dexamethasone), 30-50% of patients still develop delayed CINV. Aromatherapy with lemon, lavender, and peppermint essential oils may provide additive benefit through olfactory-limbic and vagal pathways, but phase III evidence is lacking. 374 patients (aged 18-80) scheduled for at least two HEC cycles will be randomized 1:1, stratified by prior CINV. On chemo day, aromatherapy starts 30 min before and continues until 2 h after chemotherapy; on days 2-5, inhalation is at least 2 h daily.Primary endpoint: complete response (no vomiting, no rescue antiemetic) over 0-120 h. Key secondary endpoints: acute and delayed CR rates, complete/total control rates, time to treatment failure, quality of life (FLIE), anxiety, depression, sleep quality, and safety. Exploratory: plasma GDF15 dynamics and predictive value.

Gonadotropin-Releasing Hormone Agonists Benefit in Preserving the Ovarian Function in Premenopausal Breast Cancer Patients During Chemotherapy

The purpose of this study is to investigate the benefits of gonadotropin-releasing hormone agonist administration during chemotherapy on preserving ovarian function and Fertility in Premenopausal breast cancer patients, as assessed by anti-mullerian hormone levels, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and estradiol (E2) levels.

Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer

The primary objective of this observational study is to investigate the incidence of Post Operative Delirium (POD) after gastroesophageal cancer surgery. Secondary objectives are to investigate the relationship between POD, preoperative depression, frailty, quality of life, malnutrition and sarcopenia. Participants identified with POD will be asked (at the routine follow-up meeting after surgery) to participate in an qualitative interview, in order to understand the participant's experience of postoperative delirium. The main objective aims to answer: What is the incidence of POD after gastroesophageal cancer surgery.

The Effect of a Music-Assisted Mandala Intervention on Psychological Well-being and Quality of Life in Cancer Patients Undergoing Chemotherapy

Cancer is one of the most significant global health issues of our time. Chemotherapy, one of the methods used to treat cancer, not only treats the disease but also causes numerous physiological and psychological side effects that adversely affect quality of life. It has been reported that treatment adherence problems are more common in patients with a high symptom burden associated with these side effects. For this reason, it is crucial that patients have achieved psychological adaptation to their condition and treatment in order for the treatment to be effective, to ensure that toxicity is kept under control, and to ensure that the course of the disease progresses favourably. In cases of illness and failure to adhere to treatment, this can lead to unnecessary visits to the doctor, visits to A\&E, hospitalisation, and an increase in the use of healthcare services and associated costs; it may also result in the development of treatment resistance, an increased burden on patients and carers, disease progression, and even death. Various non-pharmacological approaches, such as exercise, expressing emotions and art therapy, can be used to ensure the patient's adherence to treatment. It has been reported that mandala practice, a form of art therapy, reduces anxiety, fatigue, insomnia and stress. In light of this information, the aim of this study is to assess the effect of mandala practice on psychological adjustment to the disease and treatment, and on quality of life, in cancer patients undergoing chemotherapy.

Iparomlimab and Tuvonralimab (QL1706) Plus Lenvatinib and Chemotherapy for Extrapulmonary Neuroendocrine Carcinoma

The aim of this prospective, randomized, controlled clinical trial is to evaluate the efficacy and safety of iparomlimab and tuvonralimab injection (QL1706) plus lenvatinib and etoposide-based platinum chemotherapy, consisting of etoposide plus cisplatin or carboplatin, compared with etoposide-based platinum chemotherapy alone as first-line treatment for patients with extrapulmonary neuroendocrine carcinoma. Potential predictive biomarkers will also be explored through analyses of tumor tissue, peripheral blood, and relevant clinical and pathological data.

The Effect of a Virtual Reality-Based Mindfulness Intervention on Anxiety, Comfort, Sleep, and Fatigue in Breast Cancer Patients Undergoing Chemotherapy

Breast cancer is a public health issue with a high incidence among women worldwide, and its prevalence continues to increase each year. A breast cancer diagnosis brings significant physical, emotional, social, economic, and occupational changes. Chemotherapy, one of the most commonly used treatment modalities in cancer therapy, causes various physical and emotional symptoms while treating the disease. However, it is well known that these symptoms induced by chemotherapy can be prevented or alleviated through effective treatment and nursing interventions. Recently, virtual reality (VR) and mindfulness-based interventions have been reported as effective tools and methods for managing the physical and psychological symptoms experienced by cancer patients. The present study aims to evaluate the effect of a VR-integrated mindfulness-based intervention on anxiety, comfort, sleep, and fatigue levels among women newly diagnosed with breast cancer, both before and during chemotherapy treatment. The study is designed as a randomized controlled trial (RCT). The study population will consist of individuals diagnosed with breast cancer at the Oncology Outpatient Clinic of Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital between May 2025 and December 2026. The study sample will include female breast cancer patients who are scheduled to receive adjuvant chemotherapy, meet the inclusion criteria, and volunteer to participate in the study. According to the power analysis (with a 30% additional error margin), a total of 50 participants will be included - 25 in the intervention group and 25 in the control group. The data will be collected using the following instruments: Patient Information Form, Beck Depression Inventory, Cancer Fatigue Scale, General Comfort Questionnaire-Short Form, State Anxiety Inventory, Jenkins Sleep Scale, and the Mindfulness-Based Self-Efficacy Scale. It is expected that, as a result of this study, compared to the control group, participants in the intervention group who receive the VR-Mindfulness intervention during breast cancer treatment will demonstrate reduced levels of fatigue and anxiety and improved comfort and sleep quality.

Effect of AI-Assisted Expressive Writing on Anxiety, Emotional Distress, and Quality of Life Among Patients Receiving Chemotherapy

This study aims to evaluate the effect of an AI-assisted expressive writing intervention on anxiety, emotional distress, and quality of life among patients receiving chemotherapy. A mixed-methods, interventional research design will be employed. Participants will be assigned to either a study group receiving the AI-assisted expressive writing program in addition to routine care or a control group receiving routine care only. Quantitative data will be collected using the Depression Anxiety Stress Scale-21 (DASS-21) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Qualitative data will be obtained through semi-structured interviews to explore participants' experiences with the intervention. The findings are expected to provide evidence regarding the effectiveness of AI-assisted expressive writing as a supportive strategy for improving psychological well-being and quality of life among patients undergoing 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).

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.

Electroacupuncture for Preventing Chemotherapy-Induced Peripheral Neuropathy in Patients With Early-stage Cancer

This randomized controlled clinical trial aims to clarify the clinical efficacy and safety of electroacupuncture combined with thumbtack needle for the prevention of chemotherapy-induced peripheral neuropathy(CIPN), and to provide high-level evidence-based medicine for the prevention of CIPN in patients with early stage cancer. At the same time, the effects of electroacupuncture on the median nerve, tibial nerve, sural nerve sensory conduction velocity and sensory nerve action potential, as well as on the median nerve and tibial nerve motor conduction velocity will be analyzed.

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.

Education Effect on Comfort and Anxiety in 5-FU Elastomeric Pump Therapy

Cancer treatment often requires chemotherapy, which can be administered through portable devices called elastomeric pumps. These pumps allow medications such as 5-fluorouracil (5-FU) to be delivered continuously over an extended period while patients remain at home rather than staying in the hospital. Although this treatment approach offers greater convenience and independence, patients may experience anxiety and uncertainty related to pump use, treatment side effects, and self-care responsibilities. This study aims to determine whether providing structured education about elastomeric pump use and 5-FU treatment can improve patients' comfort and reduce anxiety. Participants receiving 5-FU chemotherapy through an elastomeric pump will be assigned to either an education group or a standard care group. Patients in the education group will receive additional training from the researcher using educational materials and a patient information booklet. The training will include information about safe pump use, management of treatment-related symptoms, precautions to take during treatment, and what to do if problems occur. Patients in the standard care group will continue to receive the routine information and care normally provided by the oncology clinic. Participants will complete questionnaires that measure comfort and anxiety before the study begins and again one month later. The results will help determine whether structured patient education improves the experience of individuals receiving outpatient chemotherapy through elastomeric pumps. The findings may help healthcare professionals develop more effective educational programs and supportive care strategies for patients receiving home-based chemotherapy.