Status:
RECRUITING
Registry Study in MSI/dMMR Solid Tumors
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
DMMR Cancer
MSI-H
Eligibility:
All Genders
18+ years
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...
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 CTL...
Eligibility Criteria
Inclusion
- Sign the informed consent form and voluntarily participate in this study;
- Age ≥ 18 years old; age should also be ≤75 years old in Cohorts B, C, D;
- Histologically or cytologically confirmed to have a solid malignant tumor and confirmed by immunohistochemistry to be dMMR or confirmed by PCR/NGS to be MSI;
- The researcher determines that the patient can receive anti-tumor treatment;
- Have evaluable lesions
Exclusion
- Other malignant tumors within 5 years before joining the study, except for cured skin squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, localized low-risk prostate cancer (defined as stage ≤T2a, Gleason score ≤6 points, and prostate cancer diagnosed with PSA ≤10 ng/mL (if measured). Patients who have received radical treatment and have no prostate specific antigen (PSA) biochemical recurrence can participate in this study), cervical/breast carcinoma in situ, and Lynch syndrome;
- Evidence already exists that the patient is a pregnant or lactating woman;
- Previous treatment with immune checkpoint inhibitors or T cell co-stimulatory drugs, including but not limited to PD1, CTLA4, LAG3, and other immune checkpoint blockers, therapeutic vaccines, etc.; patients exposed to ICIs in perioperative setting are allowed to be enrolled if disease relapse after more than 6 months since the last dose of ICIs;
- Other situations deemed by the researcher to be unsuitable for inclusion in the study
Key Trial Info
Start Date :
October 7 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT06004713
Start Date
October 7 2023
End Date
February 1 2026
Last Update
October 25 2023
Active Locations (10)
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1
Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute
Beijin, Beijing Municipality, China, 100142
2
Department of Gastroenterology and Hepatology, The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
3
Department of Oncology, The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
4
Medical Oncology Department of Gastrointestinal Cancer, Liaoning Cancer Hospital & Institute
Shengyang, Liaoning, China