Registry Study in MSI/dMMR Solid Tumors

Launched by PEKING UNIVERSITY CANCER HOSPITAL & INSTITUTE · Aug 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of new treatments for patients with specific types of solid tumors, particularly those that are classified as dMMR or MSI-H. These terms refer to certain genetic characteristics of the cancer that may influence how well it responds to treatment. The study aims to observe how these treatments work in real-life situations, especially for patients whose treatment plans are guided by specific blood tests that check for cancer-related genetic material (called ctDNA). The researchers are also looking to identify markers that might help predict how well the treatment will work for different patients.

To participate in this study, you need to be an adult between 18 and 75 years old with a confirmed diagnosis of a solid tumor and the dMMR or MSI-H characteristics. You should not have other cancers (with some exceptions), and you cannot have previously received certain cancer immunotherapies. If you join the study, you can expect to receive treatment under careful observation, and your progress will be monitored closely. This trial is currently recruiting participants, so if you meet the criteria and are interested, you can learn more about how to get involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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