Phase II Study of Toripalimab Immunotherapy to Lower Recurrence Risk After Surgery in Patients with High-Risk Mismatch Repair Deficient Colon Cancer

What this Trial Is About

Researchers are evaluating the use of immunotherapy with toripalimab to reduce the risk of cancer returning after surgery in patients with mismatch repair deficient stage IIB, IIC, or III colon cancer. This phase II trial aims to measure how well toripalimab works by assessing disease-free survival over three years and other long-term outcomes, including relapse-free survival and overall survival. The study also focuses on understanding immune-related side effects and exploring biological markers linked to treatment response and patient quality of life. Participants will receive toripalimab through intravenous infusions every three weeks for six months, totaling eight doses, provided the disease does not return and side effects remain acceptable. After finishing the treatment phase, patients will be monitored regularly with blood tests, CT scans, and colonoscopies at specific intervals for up to five years after surgery. In cases where cancer recurrence occurs, a biopsy will be performed to gather additional information. During the study, participants will complete questionnaires to report on their health and quality of life. Researchers will track disease status through imaging and laboratory assessments, and monitor for any treatment-related adverse events for up to five years. This comprehensive follow-up ensures careful observation of long-term outcomes and safety. The total participation duration may last up to five years post-surgery, including treatment and surveillance periods.

Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer