A Study of Neoadjuvant QL1706 in Participants With Untreated dMMR/MSI-H Resectable Colon C
The goal of this clinical trial is to evaluate the efficacy of neoadjuvant QL1706 in participants with untreated T4N0 or Stage III (resectable), microsatellite instability high/ defective mismatch repair (MSI-H/dMMR) colon cancer
| Condition(s) | Colon Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | The goal of this clinical trial is to evaluate the efficacy of neoadjuvant QL1706 in participants with untreated T4N0 or Stage III (resectable), microsatellite instability high/ defective mismatch repair (MSI-H/dMMR) colon cancer |
| Who can participate | Inclusion Criteria: * Signed written informed consent; * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Untreated pathologically confirmed colon adenocarcinoma * Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only). * Has a tumor demonstrating the presence of MSI-H/ dMMR * Adequate organ function as described in the protocol Exclusion Criteria: * Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc * Has distant metastatic disease. * Has an active autoimmune disease that has required systemic treatment in past 2 years * Has know history of, or any evidence of interstitial lung disease; * Has an active infection requiring sy |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Qilu Pharmaceutical Co., Ltd. |
| Locations | Guangzhou, China |
| Start date | 2024-12-12 |
| NCT ID | NCT06686576 |
| Official listing | https://clinicaltrials.gov/study/NCT06686576 |