Clinical Research Directory

Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary

Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, this treatment will negatively impact different aspects of bowel function and the patients' quality of life. These bowel symptoms often remain prevalent, even at 12 months after RC treatment. Most assessment tools are however not capable of capturing the full range or therapeutic-related evolution of these bowel symptoms. Consequently, the aim is to develop a validated bowel diary for diagnosing and evaluation of all bowel symptoms. In recent years, organ-preserving strategies such as Watch and Wait have become more widely implemented. Although these patients avoid surgical morbidity, emerging evidence shows that neoadjuvant radiotherapy alone can also cause substantial and persistent bowel dysfunction. Therefore, we expanded our study population to include patients managed with a Watch and Wait strategy in addition to those undergoing TME/PME.

Total Neoadjuvant Therapy in Rectal Cancer

In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospective enrolled. The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. The primary endpoint is the complete response (CR) rate which will take into account the patients with clinical and pathological complete response.

Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

Rectal cancer patients who do not achieve a complete response to standard of care chemotherapy and radiation often require surgical resection as part of curative intent therapy. This study will evaluate whether additional "focal" radiation delivered internally (rectal brachytherapy) can provide complete responses and thus spare the requirement for surgery. The main questions are whether: 1) rectal brachytherapy is safe in this clinical treatment paradigm and if 2) rectal brachytherapy improves organ preservation (no need for surgery). The trial involves an additional MRI pelvis and sigmoidoscopy with marker placement to define high-risk residual disease for radiation planning. Subsequently, 3 outpatient brachytherapy treatments are given on a weekly basis. If a patient achieves a complete response to brachytherapy, standard of care non-operative surveillance visits are conducted with study visits aligned during the first two years following brachytherapy.

Clinical and BIOgical Analyses of RECtal Tumors

Rectal cancer is a common cancer with an incidence of approximately 14,000 new cases per year in France. The survival rate is approximately 50% at 5 years, ranging from 90% for patients with localized rectal cancer to 18% for patients with metastases. Surgery with local or complete exicion is the standard treatment for early stages. The implementation of Total Neoadjuvant Therapy (TNT) for locally advanced stages has led to a significant improvement in the prognosis for rectal cancer. The complete pathological response rate of aproximately 20% after TNT has led to the "Watch and Wait" strategy, which aims to avoid surgery and preserve the rectum, but there is currently no reliable method for identifying responders. Rectal tumors with mismatch repair defiency (MMRd) and/or High microsatellite instability (MSI-H) are considered resistant to neoadjuvant chemotherapy, but those patients can benefit from immunotherapy treatment. Identifying patients who will respond to immunotherapy is crucial for this type of treatment. Pre-existing immune infiltration within the tumor microenvironnement prior to any treatment is an important prognostic factor and could help predict response to immunotherapy, as well as neoadjuvant treatment. Studying the immune microenvironnement and how it changes during different treatments could therefore help identify responders for whom treatment without surgery could be considered in order to avoid the deterioration in quality of life often associated with this procedure in this type of cancer. Finally, analysis of residual tumor cells after chemotherapy and/or chemoradiotherapy could help identify possible mechanisms of resistance to current treatments and develop strategies to counter them.

Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Locally Advanced HER2-expressing Rectal Cance

After signing the informed consent form, patients who met the inclusion and exclusion criteria were given the full course of neoadjuvant treatment: short-term radiotherapy, followed by 6 consecutive cycles of disitamab vedotin, combined with sintilimab and capecitabine, and within 3-4 weeks after the last dose, they underwent preoperative imaging examinations to evaluate the efficacy of the neoadjuvant treatment and the possibility of total mesorectal excision. Whether adjuvant therapy was performed after surgery was determined by the investigators.

Efficacy and Safety Comparison of Short-course Radiotherapy Followed by CapeOX Chemotherapy Plus Toripalimab With or Without Concurrent Surufatinib in Neoadjuvant Therapy for Mid-to-low Localized Rectal Cancer of High-risk Criteria

Why is this study conducted? The purpose of this study is to improve the treatment efficacy, particularly the pathological complete response rate, in patients with high-risk/extremely high-risk locally advanced rectal cancer (LARC). In recent years, with the combination of neoadjuvant chemoradiotherapy and immunotherapy, some progress has been made in the treatment of rectal cancer, but there are still problems of regional recurrence and distant metastasis. Therefore, developing new treatment strategies for these patients is particularly important. The treatment of rectal cancer usually involves surgery, radiation therapy, and chemotherapy. The current treatment methods have gradually shifted towards neoadjuvant chemoradiotherapy combined with immunotherapy, and have shown good potential in some clinical trials. These studies suggest that combining short-range radiotherapy, anti angiogenic drugs, and immune checkpoint inhibitors may play an important role in improving patient prognosis and enhancing tumor response rates. However, the efficacy and safety of these plans in high-risk patients still need further validation. In this context, the aim of our study is to compare the efficacy and safety of neoadjuvant short-course radiotherapy followed by four cycles of CapeOX chemotherapy combined with toripalimab, with or without concurrent surufatinib, in patients with mid-to-low locally advanced rectal cancer with high-risk factors identified by MRI (including any one or more of the following: cT4, cN2, EMVI+, MRF/CRM+, or lateral lymph node metastas. This study aims to promote treatment optimization for LARC patients and provide new ideas for future treatments. Why are you invited to participate in this study? We would like to invite you to participate in this study as you have been diagnosed with high-risk or extremely high-risk locally advanced rectal cancer, which meets the inclusion criteria of this study. Specifically, you need to meet the conditions for pathological diagnosis, have a suitable tumor location, and not have serious comorbidities or other excluded diseases (such as recurrent rectal cancer, cardiac dysfunction, etc.). The final selection will be determined by the research doctor based on your actual situation. What do you need to do to participate in this study? Participating in this study will require you to follow a series of steps. You need to undergo regular medical examinations and evaluations, including blood tests, imaging examinations, and anorectal function assessments. During the research period, you may also need to fill out a questionnaire and provide some biological samples (such as blood samples), which will be used for the analysis of drug efficacy. The frequency and specific content of each follow-up will be informed by the research team to ensure your participation throughout the entire treatment process. I hope you can cooperate with these research steps to help us better understand the effectiveness of this treatment plan. What are the risks of participating in this study? This study involves the use of neoadjuvant short course radiotherapy, PD-1 monoclonal antibody (Terizumab), and anti angiogenic therapy (Sofantinib). Participants may face the following risks: Risk of neoadjuvant short course radiotherapy: Participants may experience severe side effects (≥ grade 3), including but not limited to severe diarrhea, third degree neutropenia, and third degree radiation dermatitis. These side effects may seriously affect the quality of life of patients. Risk of PD-1 monoclonal antibody: Terriptylimab may cause immune related adverse reactions (irAEs), which can involve any organ. The commonly known irAEs include skin toxicity (such as papules and itching, with an incidence of 30% to 40%), diarrhea and/or colitis (8% to 19%), fatigue (16% to 24%), immune related hepatitis (5%), hypothyroidism (4% to 10%), and hyperthyroidism (4%). Overall, nearly two-thirds (about 2/3) of patients receiving immune checkpoint inhibitor therapy will experience varying degrees of irAEs, and the incidence of serious adverse events cannot be ignored. Risk of anti angiogenic therapy: The use of sorafenib may lead to adverse reactions related to its anti angiogenic and immunomodulatory effects. Known common adverse reactions include proteinuria, hypertension, bleeding, liver dysfunction, diarrhea, etc., with an incidence rate of over 20%. Among serious adverse events (≥ grade 3), hypertension (29.7%), proteinuria (14.5%), liver dysfunction (12.8%), and bleeding (4.5%) are the most common. In rare cases, treatment-related deaths may occur due to gastrointestinal bleeding, cerebral hemorrhage, etc. Handling of research related injuries? This study is an intervention study that does not add any additional risks beyond routine clinical diagnosis and treatment. If you suffer harm due to participating in the study, compensation or liability will be determined in accordance with relevant laws and regulations.

Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer

Data from a prior phase II study of single agent cabozantinib in metastatic, refractory colorectal cancer (NCT03542877) combined with the compelling preclinical data in colorectal mouse models utilizing cabozantinib combined with nivolumab have led to this concept for a clinical trial to combine cabozantinib and nivolumab in patients with metastatic MSS CRC in the third line setting and beyond.

Registry Maastro Applicator

This registry will collect data from all patients treated with the MAASTRO HDR applicator. The goal is to deepen knowledge about dose-response relationships in rectal cancer boosting, which is essential for improving future treatment approaches and patient selection.

The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-preserving Surgery

The goal of this clinical trial is to explore the difference in 3-year stoma-free survival between the Turnbull-Cutait delayed coloanal anastomosis (TCA) surgery and the low anterior resection combined with protective stoma (LAR) surgery in patients with low rectal cancer, as well as the differences in anal function, surgical complications, and survival outcomes within 1 year after surgery. The main questions it aims to answer are: 1. Is TCA surgery superior to LAR surgery in improving the 3-year stoma-free survival of patients with low rectal cancer? 2. Are there differences in postoperative anal function (assessed by LARS score and Wexner score), quality of life (assessed by EORTC QLQ-CR29 questionnaire), surgical complications, pathological outcomes, and long-term survival (disease-free survival, time to recurrence, overall survival) between the two surgical methods? Researchers will compare the TCA group and the LAR group to see if TCA surgery can reduce the permanent stoma rate, improve postoperative anal function and quality of life, and ensure surgical safety and favorable tumor-related outcomes compared with LAR surgery. Participants will: 1. Be randomly assigned to either the TCA group or the LAR group in a 1:1 ratio. 2. Receive the corresponding surgical intervention. 3. Complete regular follow-ups at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, and 36 after the first surgery. 4. Provide relevant clinical data (perioperative, pathological, follow-up) as required.

Developing and Testing the Effect of Online Interactive Videos in Improving Low Anterior Resection Syndrome.

This study aims to develop and test the effect of online interactive videos in improving LARS.

Hypofractionated Palliative Radiotherapy in Patients With Advanced Non-operable Rectal Cancer

Many patients with rectal cancer were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases. In this scenario only comfort measures or different palliative radiotherapy regimens are applied, from single doses to treatments lasting several weeks. The aim of this prospective study is to describe the preliminary results of our protocol of hypofractionated palliative radiotherapy in patients with non-operable rectal cancer.

Next Generation STAR-TREC (NG-ST) - Organ Preservation in Early Rectal Cancer

This study evaluates whether mesorectal chemoradiotherapy with a limited radiation target volume can achieve a sustained clinical complete response in patients with early-stage rectal cancer, allowing surgery to be safely deferred. Patients may choose between standard total mesorectal excision (TME) surgery or organ preservation with chemoradiotherapy followed by structured surveillance. The study aims to assess oncologic safety, organ preservation rates, and quality of life.

Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late-Line Metastatic Colorectal Cancer

This study is to evaluate the disease control rate and time to progression of the sequential combination of oxaliplatin with an alternative anti-metabolite Trifluridine/tipiracil hydrochloride mixture, TAS-102,(TAS-OX) as well as irinotecan in combination with TAS-102 oxaliplatin(TAS-OX) + Bevacizumab in late-line metastatic colorectal cancer (mCRC)

A Study of Response to Standard Treatment Before Surgery in People With Rectal Cancer

The purpose of the study is to learn more about how the body responds to standard treatment (chemoradiation and chemotherapy). The study will use the results of testing down on participants' blook, tissue, and scans to learn more about how people with rectal cancer respond to chemoradiation and chemotherapy treatment and if it is useful for predicting whether a person's cancer get better, gets worse, or stats the same after treatment.

A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)

This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to: * Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting * Evaluate the safety of the combination of fruquintinib + FOLFIRI

Resilience and Equity in Aging, Cancer, and Health (REACH)

The purpose of this multi-phase research study is to understand how consultation of cancer care with a geriatrician can best improve outcomes for older adults with gastrointestinal malignancies.

SIS-Reinforced vs. Conventional Anastomosis for Mid-to-Low Rectal Cancer: A Multicenter RCT on Anastomotic Leak

The goal of this clinical trial is to learn whether using a reinforcing material called SIS (small intestinal submucosa) during bowel connection after rectal cancer surgery can help prevent anastomotic leakage-a serious complication where the connection between two parts of the intestine fails to heal properly. This study will focus on patients with mid-to-low rectal cancer who are scheduled for surgery. The main questions the study aims to answer are: Does using an SIS-reinforced connection reduce the rate of anastomotic leakage within 30 days after surgery compared to standard connection methods? Does it also reduce the need for a temporary stoma (an opening in the abdomen for waste removal)? Researchers will compare two groups: Intervention group: Patients who receive the SIS-reinforced connection during surgery. Control group: Patients who receive the standard connection without reinforcement. Participants in this study will: Be randomly assigned to either the intervention or control group. Undergo standard laparoscopic or robot-assisted rectal cancer surgery. Be followed up at 30 days, 90 days, and 12 months after surgery to check for complications, stoma status, and quality of life. This study is being conducted across multiple hospitals in China to ensure the results are reliable and widely applicable.

FOLFIRINOX Induction Chemotherapy for Synchronous Liver Metastases

SYNCHRONOX is a multicenter cohort (retrospective then prospective) intending to include 550 patients with mid or low rectal adenocarcinoma (pMMR, T3-T4 and/or N+) and resectable synchronous liver metastases, treated upfront with at least two cycles of induction FOLFIRINOX chemotherapy. The primary objective is to determine, at 18 months, the R0 resection rate of both tumor sites (rectum and liver), while secondary objectives focus on 3 year overall and progression free survival, radiological and pathological responses, postoperative morbidity and mortality, and comparison of the different surgical strategies after FOLFIRINOX.

The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study

The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.

A Study of Tucatinib and Trastuzumab in People With Rectal Cancer

The study researchers believe that a combination of the drugs trastuzumab and tucatinib, given with standard chemotherapy (capecitabine and oxaliplatin/FOLFOX), may help participants with rectal cancer.

Neoadjuvant mFOLFOXIRI Plus Bevacizumab in Patients With High-Risk Locally Advanced Rectal Cancer

Multimodality treatment that comprises preoperative fluoropyrimidine with concurrent radiotherapy followed by total mesorectal excision (TME) surgery and adjuvant fluoropyrimidine-based chemotherapy is recommended as a standard treatment of patients with stage II/III rectal cancer. However, the main target of radiotherapy is local control but no improvement in disease-free survival (DFS) or overall survival (OS) has been shown with this treatment strategy, which leaves approximately 30% of patients in whom distant metastases will develop. Moreover, the short- and long-term adverse effects of radiotherapy such as chronic pain, faecal incontinence and urogenital/anal dysfunction are associated with poor quality of life. Neadajuvant chemotherpay (NACT) alone has been proposed instead of preoperative chemoradiotherapy (CRT) with the aim of elimination of potential micrometastasis as early as possible while avoiding the adverse effects of radiotherapy, without jeopardizing local control. Evidence from the UK CR07 trial suggests that, without RT, a local recurrence rate of 5% (27/543) can be achieved if a complete mesorectal excision is carried out with a negative CRM. A small single-center phase II pilot trial treated patients with stage II or III rectal cancer with induction FOLFOX/bevacizumab chemotherapy followed by CRT only in those with stable or progressive disease and resection in all patients. All 32 of the participants had an R0 resection, and the 4-year DFS was 84%. Another phase II trial, which included 60 patients with stage II/III rectal cancer, assessed the R0 resection rate after FOLFOX plus either bevacizumab or cetuximab. An R0 resection was achieved in 98.3% of the participants, and the pathologic complete response rate was 16.7%. The phase III FOWARC trial, compared neoadjuvant therapy with and without radiation and found that perioperative mFOLFOX6 alone led to a similar downstaging rate as fluorouracil-radiotherapy, and no significant difference in outcomes was found between mFOLFOX6 without radiotherapy and 5-FU- radiotherapy. On the basis of the results of these trials, The investigators hypothesized that radiotherapy could be selectively omitted for patients who respond to NACT alone. The results of TRIBE showed that FOLFOXIRI plus bevacizumab yield a high objective response rate (ORR) (65%), early tumor shrinkage (ETS) (62.7%) and depth of response (DoR) (43.4%) in patients with metastatic colorectal cancer. The investigators were motivated to investigate this triplet-drugs chemotherpay plus bevacizumab both by the possibility of avoiding the toxicities of radiation without compromising local control, and the possibility that earlier introduction of intensive systemic therapy might achieve rapid tumor shrinkage, and improve distant control. The investigators conducted this phase III trial to compare neoadjuvant mFOLFOXIRI plus bevacizumab with selective radiotherapy with induction FOLFOX followed by concomitant chemoradiotherapy in patients with high-risk locally advanced rectal cancer.

Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in Locally Advanced Rectal Cancer (UNION)

The study is a multicenter, open-label, randomized controlled clinical study, and the purpose of the study is to compare the pathological complete response rate (PCR) of patients with locally advanced rectal cancer treated with short-term radiotherapy, sequential Camrelizumab and CAPOX (group A) to long-term concurrent chemoradiotherapy, sequential CAPOX (group B) in patients with LARC. A total of 230 patients were included in this study.

Quality Of Life In Colorectal Cancer Survivors

The purpose of this study is to identify late adverse effects in colorectal cancer patients that may influence quality of life at 6, 12, and 24 months after oncological treatment. The study aims to assess quality of life in colorectal cancer survivors in relation to psycho-physical-social well-being at different time points and to evaluate the prevalence of late adverse effects and their association with diagnosis and specific oncological treatment.

Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes

Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain. To address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.