SCRT-CAPEOX-Serplulimab for MSS/pMMR Rectal Cancer With Oligometastases
Background and Significance: Colorectal cancer (CRC) ranks as the third most common cancer and the second leading cause of cancer-related deaths globally. Despite improved early screening rates, a significant proportion of newly diagnosed CRC patients present with synchronous metastases, predominantly liver metastases.
| Condition(s) | Colorectal Carcinoma, Oligometastases, pMMR, MSS, iTNT |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | Background and Significance: Colorectal cancer (CRC) ranks as the third most common cancer and the second leading cause of cancer-related deaths globally. Despite improved early screening rates, a significant proportion of newly diagnosed CRC patients present with synchronous metastases, predominantly liver metastases. The concept of oligometastases, introduced by Hellman and Weichselbaum in 1995, describes a transitional state between localized disease and widespread metastases, characterized by limited metastatic lesions (typically 1-5) confined to 1-2 organs. Current Treatment Landscape: The management of oligometastatic disease combines local therapeutic approaches (surgery, radiotherapy, radiofrequency ablation) with systemic treatments, aiming to achieve No Evidence of Disease (NED) |
| Who can participate | Inclusion Criteria: \- Has signed the written Informed Consent Form (ICF) and is able to comply with protocol-specified visits and procedures. Age between 18-75 years. Histologically confirmed primary rectal adenocarcinoma, with MRI showing tumor location within 10cm from the anal verge. Synchronous oligometastatic rectal cancer confirmed by comprehensive imaging evaluation (contrast-enhanced CT, contrast-enhanced MRI, PET-CT, etc.), with ≤2 metastatic sites and ≤5 total metastatic lesions. Microsatellite stability status confirmed as MSS (using the NCI-recommended 5 microsatellite markers: BAT25, BAT26, D5S346, D2S123, D17S250) or proficient mismatch repair (pMMR) status confirmed by immunohistochemistry showing positive nuclear expression of all 4 MMR proteins (MLH1, MSH2, MSH6, PMS2). A |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | First Affiliated Hospital of Zhejiang University |
| Locations | Hangzhou, Zhejiang, China |
| Start date | 2025-04-22 |
| NCT ID | NCT06850103 |
| Official listing | https://clinicaltrials.gov/study/NCT06850103 |