View clinical trials related to MSI-H.
Filter by:This study is a multi-center, non-interventional, prospective clinical observational study, aiming to evaluate the effectiveness and safety of subsequent treatment in dMMR/MSI solid tumor patients who have never received ICIs under real-world conditions. Particular attention is paid to the efficacy in populations where treatment plans are adjusted based on ctDNA, and potential predictive or prognostic biomarkers are explored.
Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer
This is a two-group, parallel, randomized, standard-control phase II study comparing the safety and efficacy of immunotherapy versus standard chemotherapy in patients undergoing T4NX/TXN+ colon cancer surgery with MSI-H or POLE/ POLD1 mutations.This study was conducted in the Department of Gastroenterology, Tumor Hospital of Tianjin Medical University. Patients with MSI-H or POLE/ POLD1 gene mutations confirmed by PCR sequencing or NGS sequencing will be randomly assigned (2:1) to immunotherapy (experimental group) or standard chemotherapy (control group) after signing informed consent. In this study, 30 patients will be enrolled, 20 patients will receive immunotherapy and 10 patients will receive standard chemotherapy. In the immunotherapy group, the treatment regimen was Tirelizumab 200mg, intravenously infused once every 3 weeks until the end of 12 months of treatment, with a total of 17 infused times. Patients enrolled in this group could enjoy the preferential policy of purchasing 7 times and giving 10 times at their own expense. The chemotherapy regimen of the standard chemotherapy group was XELOX regimen, oxaliplatin 130mg/m2, d1, capecitabine 1000mg/m2, orally, bid (half an hour after breakfast and dinner), d1-14, every 21 days. The duration of treatment was determined according to the patient's postoperative pathological stage (3 months for T4N0/ T1-3N1 and 6 months for T4N+/ T1-3N2). Patients received regular and periodic reviews, with imaging evaluations every 3 months for the first 2 years and every 6 months after 2 years. Safety will be evaluated by AE and laboratory tests. After tumor recurrence or metastasis was first detected, tumor tissue biopsies were taken again for NGS sequencing, and all patients were followed up every 3 months until death according to the plan.
This prospective, single-arm study is conducted to investigate the safety and efficacy of Sintilimab combined with hypofractionated radiotherapy in patients with microsatellite instability-high (MSI-H)/ DNA mismatch repair-deficient (dMMR) non-metastatic rectal cancer.