Spots Global Cancer Trial Database for Registry Study in MSI/dMMR Solid Tumors
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Trial Identification
Brief Title: Registry Study in MSI/dMMR Solid Tumors
Official Title: Multi-center, Non-interventional, Prospective Registry Study on the Treatment of Solid Tumors With Mismatch Repair Deficiency or Microsatellite Instability
Study ID: NCT06004713
Interventions
Study Description
Brief Summary: 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.
Detailed Description: This study plans to enroll patients in the following four cohorts: * Cohort A: Initially only receiving PD1/PDL1 monotherapy; * Cohort B: Initially receiving simultaneous blockade of PD1/PDL1 and CTLA4; * Cohort C: Initially receiving PD1/PDL1 monotherapy combined with chemotherapy or targeted therapy; * Cohort D: Initially not using ICIs, receiving other standard treatments for this tumor type To explore the role of ctDNA testing in therapeutic decision-making, patients with the first evaluation of SD in cohort A are divided into two groups: ctDNA testing/intervention group (Group A1) and ctDNA testing/non-intervention group (Group A2). In group A1, if there is no early response to ctDNA, the researchers and the patient will decide to add CTLA4 antibody or other potentially effective treatments after thorough communication. If there is an early response to ctDNA, then continue with PD1/PDL1 monoclonal antibody treatment. Patients in group A2 undergo ctDNA testing, but still continue with PD1/PDL1 monoclonal antibody treatment according to the RECIST v1.1 standard when the first evaluation of SD is made. Meanwhile, explore the role of 1-year ctDNA-MRD in guiding treatment in patients with long-term tumor control, and explore the guiding role of re-biopsy of tumor tissue or ctDNA testing in helping making treatment regimen after progression on ICIs. Number of Subjects: • This study will recruit patients nationwide for data collection over a period of 3 years. The plan is to enroll 100 cases in Cohort A, including 25 cases in Group A1 and 25 cases in Group A2; 30 cases in Cohort B; 30 cases in Cohort C; and 30 cases in Cohort D.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijin, Beijing, China
Department of Gastroenterology and Hepatology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Medical Oncology Department of Gastrointestinal Cancer, Liaoning Cancer Hospital & Institute, Shengyang, Liaoning, China
Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
Department of Gastroenterology, Shanxi Province Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital, Taiyuan, Shanxi, China
Department of Medical Oncology, Peking University First Hospital, Beijing, , China
Department of Oncology, Beijing Luhe Hospital Affiliated to Capital Medical University, Beijing, , China
Department of Oncology, Peking University Shougang Hospital, Beijing, , China
Department of Gastrointestinal Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, , China
Contact Details
Name: zhenghang Wang
Affiliation: Peking University Cancer Hospital & Institute
Role: STUDY_DIRECTOR
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