Neoadjuvant Immunotherapy ± Radiotherapy in MSI-H/dMMR Locally Advanced Colorectal Cancer (NCT07403877) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant Immunotherapy ± Radiotherapy in MSI-H/dMMR Locally Advanced Colorectal Cancer
China114 participantsStarted 2026-02-01
Plain-language summary
This phase II clinical trial evaluates the efficacy and safety of three neoadjuvant regimens in patients with locally advanced microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) colorectal cancer (CRC): 1) Regimen A: Dual immune checkpoint blockade with nivolumab plus ipilimumab. 2) Regimen B: Nivolumab plus radiotherapy. 3) Regimen C: Nivolumab monotherapy. The primary objectives are to determine whether: 1) Dual immune checkpoint blockade (Regimen A) is superior to nivolumab monotherapy (Regimen C); and 2) Immunotherapy plus radiotherapy (Regimen B) is superior to nivolumab monotherapy (Regimen C). Methods: Participants will be randomized in a 1:1:1 ratio to one of the three arms. For patients with resectable tumors, surgical resection will be performed. In patients with low rectal cancer and poor prospects for sphincter preservation, a watch-and-wait (WW) strategy is an option if a clinical complete response (CR) is achieved following neoadjuvant therapy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Radiographic assessment showed a stage II-III based on AJCC Stage 8th ed.
✓. At least 18 years old.
✓. MSI-H or dMMR.
✓. The Eastern Cooperative Oncology Group performance status (ECOG PS) score is 0 or 1.
✓. Physical state or organ function can tolerate the planned treatment of the study protocol.
✓. Agreed to sign written informed consent before recruitment.
Exclusion criteria
✕. Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
✕. Pregnancy or breastfeeding women.
✕. History of other malignancies within 5 years.
What they're measuring
1
Complete regression (CR) rate
Timeframe: 1 month after surgery or the completion of neoadjuvant therapy
. Serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
✕. Immunodeficiency disease or long-term using of immunosuppressive agents.
✕. Allergic to any component of the therapy.
✕. Any other condition or disease that is not suitable to take the therapy included in the protocol.
✕. Concurrent participation in another clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study.