Montbeliard

Researchers are evaluating a combination treatment involving radiotherapy, three chemotherapies (docetaxel, cisplatin, and 5-fluorouracil), and spartalizumab, an anti-PD-1 therapy, for patients with metastatic squamous cell carcinoma of the anus (SCCA). This phase II study aims to improve outcomes for patients who have metastatic or locally advanced recurrent SCCA, as current chemotherapy standards have limitations and resistance to immunotherapy is common. The trial also investigates how these treatments may work together to enhance the immune response against the cancer. The treatment includes administering the modified DCF chemotherapy regimen alongside spartalizumab and radiotherapy. Blood samples are collected at multiple points: before treatment, after delivering 8 Gy of radiotherapy, and at 6 and 12 months after inclusion. These samples help monitor immune responses and tumor DNA changes. The chemotherapy and immunotherapy are given in combination to assess safety and effectiveness in this patient group. Participants will undergo regular scans including CT and PET scans to assess tumor response, and blood tests for immune and molecular analysis. Progression-free survival at one year is the main outcome being measured. The study also carefully monitors side effects and treatment safety. Participants' involvement includes baseline assessments and follow-up visits extending up to at least 12 months to observe treatment effects and collect biomarker data.

Multicenter phase II trial evaluating different strategies of pre-specified fluoropyrimidine-dose adjustment according to \[U\] in DPD-deficient patients with gastrointestinal cancer.

Researchers are evaluating the combination of a CD4 helper T-inducer cancer vaccine derived from telomerase (called UCPVax) with anti-PD-L1 therapy (atezolizumab) and bevacizumab in patients with unresectable hepatocellular carcinoma (HCC). This randomized phase II trial involves 105 patients across 10 centers and aims to determine the clinical benefit and immune response effectiveness of this combined treatment by measuring the objective response rate at 6 months. Participants receive atezolizumab at 1200 mg intravenously every 3 weeks and bevacizumab at 15 mg/kg intravenously every 3 weeks until disease progression or unacceptable side effects occur. Alongside these drugs, patients are given the UCPVax vaccine combined with an adjuvant (Montanide ISA51) at a dose of 0.5 mg subcutaneously. The study evaluates whether this combined immunotherapy approach can improve outcomes for patients with advanced liver cancer. During the trial, patients are closely monitored with assessments to evaluate tumor response using mRECIST guidelines. Researchers collect data on the treatment's clinical activity, immune system effects, and safety over the course of therapy. The main outcome measured is the objective response rate at 6 months. The trial also includes safety monitoring and follows patients to understand the treatment's impact on disease progression and overall health.

Colorectal cancer is a common cancer with increasing cases each year. Early detection is very important, and in France, people aged 50 to 74 are screened using a fecal immunological test to find hidden blood in the stool. If this test is positive, a colonoscopy is performed to check for polyps or cancer. Due to delays caused by the COVID-19 pandemic, researchers are exploring a new blood test to quickly identify patients with colorectal cancer and help guide timely treatment. The study involves two groups of patients: Cohort A includes those with suspected colorectal cancer after a positive stool test or visible bleeding, and Cohort B includes patients diagnosed with adenocarcinoma confirmed by pathology before surgery. Blood samples will be collected before colonoscopy or surgery and again one month after surgery to analyze various blood components. Tumor tissue will also be collected during surgery for study purposes. Stool samples are collected before and after surgery in Cohort B. Participants will undergo these sample collections and evaluations as part of the study. Researchers will measure how accurately the blood test detects colorectal cancer and its correlation with disease stage. The main outcomes are the sensitivity and specificity of the blood test one month after surgery, about six months after joining the study. The study is designed to improve patient care during challenges like epidemics by providing a new tool for early cancer detection and treatment planning.

Researchers are studying blood biomarkers to better distinguish malignant pancreatic lesions from benign ones. Currently, there is no approved blood test to aid in diagnosing pancreatic cancer. This study aims to identify biological markers linked to malignant pancreatic lesions by comparing patients with malignant tumors to those with benign pancreatic conditions, using samples from an existing cohort called Pancreas-CGE. The goal is to create a clinical and biological signature that can efficiently predict the presence of malignant pancreatic lesions. Participants will provide a blood sample at the start of the study for analysis. The research focuses on evaluating candidate biomarkers identified in prior work, as well as exploring additional markers. The study involves one baseline visit during which blood is collected and pancreatic lesions are assessed through radiological, echo-endoscopic, and pathological characteristics to determine whether lesions are malignant or benign. Participants will be evaluated at a single visit where their pancreatic lesion's nature will be assessed using imaging and pathology reports. The primary outcome measures the distinction between malignant and benign lesions. This study involves adults aged 18 and older who are being followed for benign pancreatic lesions, including chronic or prior acute pancreatitis, and who are scheduled for echo-endoscopy due to suspicious precancerous or cystic pancreatic lesions.

Researchers are evaluating how anti-tumor T cell responses change in adults with lung or head and neck cancer who receive combined radiochemotherapy as their initial treatment. The study focuses on understanding immune responses in patients undergoing this standard cancer therapy. Participants will receive first-line concomitant radiochemotherapy. During the study, blood and tumor tissue samples will be collected to analyze tumor antigen-specific T-cell responses. These immune responses will be monitored for up to 12 months after completing radiochemotherapy to assess modulation over time. Participants will be involved in providing biological samples and attending follow-up visits for immune response assessments. Researchers will track the tumor antigen-specific T-cell responses as the primary outcome, ensuring patients provide informed consent and meet eligibility criteria. The study includes ongoing monitoring during and after treatment to better understand immune changes related to the therapy.

Researchers are evaluating treatments for frail patients with advanced, recurrent, or metastatic adenocarcinoma of the stomach, esophagus, or gastroesophageal junction that do not overexpress HER2. This randomized Phase II trial compares two chemotherapy combinations: Trifluridine/Tipiracil plus Oxaliplatin with or without Nivolumab, versus the FOLFOX regimen with or without Nivolumab. The study aims to assess progression-free survival over up to five years from randomization. The treatments include Trifluridine/Tipiracil given in 14-day cycles with doses twice daily for 5 days followed by 9 days of rest, and Oxaliplatin administered intravenously every two weeks with a gradual dose increase during the first eight cycles. In the FOLFOX group, patients receive Folinic Acid, Oxaliplatin, and 5-fluorouracil in a two-week cycle. Nivolumab infusions occur every two weeks for up to two years or until disease progression or intolerable toxicity. After eight cycles or if neuropathy occurs, Oxaliplatin is stopped, and the other drugs continue alone until progression or intolerance. Participants will be monitored through evaluations of tumor lesions, organ function, and adverse effects. Outcome measures focus on time without disease progression or death. Safety monitoring includes regular blood tests and assessments of side effects. Participants provide consent and must be available for treatment and follow-up during the study duration, which may extend up to five years. Archived tumor samples will be collected for additional research purposes.

Researchers are investigating treatments for locally advanced anal squamous cell carcinoma, a rare but increasing cancer often linked to human papillomavirus (HPV). The study compares standard chemoradiotherapy, which combines radiation and chemotherapy with 5FU and mitomycin-C, to a new approach adding induction chemotherapy (modified DCF protocol) before the standard chemoradiotherapy. This randomized phase 3 trial aims to improve disease-related event-free survival and other outcomes such as overall survival, colostomy-free survival, treatment tolerability, response rate, and quality of life in patients with T3-T4 or N1 stage anal cancer without metastasis. Participants in the experimental group receive four cycles of induction chemotherapy (docetaxel, cisplatin, and 5-FU given every two weeks), followed by standard chemoradiotherapy consisting of 33 sessions of radiation over 6.5 weeks combined with mitomycin during weeks 1 and 5 and capecitabine taken on radiation days. The control group receives only the standard chemoradiotherapy. Radiation is delivered using intensity-modulated external irradiation (IMRT-SIB) targeting the pelvis and tumor area with specified doses. During the study, patients undergo follow-up visits starting 8 weeks after treatment, then every 4 months for two years, and every 6 months for a final year. Follow-up includes clinical exams and imaging tests such as CT and MRI. The study measures disease-related event-free survival at 2 years after treatment completion as the primary outcome. Participants must be adults aged 18 or older with measurable tumors on MRI and able to receive chemotherapy and radiotherapy, with additional health criteria assessed before enrollment.

Researchers are evaluating the effect of combining Regorafenib with metronomic chemotherapy and low-dose aspirin versus using standard Regorafenib treatment alone in patients with metastatic colorectal cancer that is resistant to chemotherapy. This phase 2 study aims to compare the progression-free survival between these two treatment approaches to understand if the combination offers any benefit. Participants receive Regorafenib following a special dosing schedule called "REDOS" during the first cycle, gradually increasing doses over three weeks then taking a week off. After the first cycle, the dose is adjusted based on tolerance. In the combination group, patients also take daily metronomic chemotherapy drugs cyclophosphamide and capecitabine for six months, along with low-dose aspirin until disease progression. The treatment continues until unacceptable side effects or cancer progression. During the study, participants undergo blood samples for plasma and circulating tumor DNA, as well as fresh tumor biopsies at baseline and week 8. Quality of life is assessed repeatedly using specific questionnaires at multiple time points up to one year and at treatment end and follow-up visits. Researchers monitor progression-free survival as the primary outcome, with safety and treatment tolerability tracked throughout. The total study duration includes treatment and follow-up phases, ensuring comprehensive assessment of effects and patient well-being.

This research aims to evaluate the use of regorafenib combined with metronomic chemotherapies and low-dose aspirin as a two-month induction treatment before starting standard chemotherapy in patients with metastatic colorectal cancer who have progressed after first-line therapy. The study is an open-label, randomized Phase II-III trial focusing on patients with specific molecular characteristics and measurable disease, assessing the treatment's impact on tumor response and overall survival. Participants will receive regorafenib administered three weeks out of four for two months, starting with a dose escalation schedule in the first cycle and adjusted based on tolerance in the second cycle. Alongside regorafenib, patients will take low doses of capecitabine and cyclophosphamide daily, plus aspirin once daily for two months. After this induction period, standard chemotherapies such as Bevacizumab, FOLFIRI, or FOLFOX will be given every two weeks according to the investigator's choice until disease progression or unacceptable side effects. Throughout the study, participants will complete quality of life questionnaires and provide blood samples for plasma and circulating tumor DNA collection. Researchers will monitor tumor response from the first treatment administration until disease progression over an average of 14 months in Phase II, and overall survival until study completion over about 64 months in Phase III. Safety, treatment adherence, and various laboratory and imaging evaluations will be conducted to assess treatment effects and participant health over time.