Registry Study in MSI/dMMR Solid Tumors (NCT06004713) | Clinical Trial Compass
UnknownNot Applicable
Registry Study in MSI/dMMR Solid Tumors
China190 participantsStarted 2023-10-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Progression-free survival (PFS) determined by the researchers according to the RECIST 1.1 criteria..
Timeframe: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose
Trial details
NCT IDNCT06004713
SponsorPeking University Cancer Hospital & Institute