Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair
This phase II trial tests how well immunotherapy (toripalimab) works for reducing the risk of cancer recurrence after surgery in patients with mismatch repair deficient stage IIB, IIC, or III colon cancer.
| Condition(s) | Localized Colon Carcinoma, Stage IIB Colon Cancer AJCC v8, Stage IIC Colon Cancer AJCC v8, Stage III Colon Cancer AJCC v8 |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This phase II trial tests how well immunotherapy (toripalimab) works for reducing the risk of cancer recurrence after surgery in patients with mismatch repair deficient stage IIB, IIC, or III colon cancer. |
| Who can participate | Inclusion Criteria: * Patients with resected pathologic stage IIB, IIC and III dMMR colon cancer (American Joint Committee on Cancer \[AJCC\] 8) * Deficient mismatch repair (MMR) by immunohistochemistry or microsatellite instability (MSI-H) by polymerase chain reaction (PCR) or next generation sequencing (NGS) * Complete (R0) resection of pathologic stage IIB, IIC and III dMMR colon cancer 4 to 12 weeks prior to first dose of study drug * Available tissue sample from surgical specimen * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Absolute neutrophil count (ANC) ≥ 1,500 /mcL * Platelets ≥ 100,000 / mcL * Hemoglobin ≥ 9 g/dL or ≥ 5.0 mmol/L * Transfusion is allowed to obtain an adequate hemoglobin level * Creatinine ≤ 1.5 x upper limit of normal (ULN) or measure |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Emory University |
| Locations | Atlanta, Georgia, United States; Atlanta, Georgia, United States; Atlanta, Georgia, United States; Atlanta, Georgia, United States; Johns Creek, Georgia, United States |
| Start date | 2025-09-19 |
| NCT ID | NCT07140679 |
| Official listing | https://clinicaltrials.gov/study/NCT07140679 |