Total Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (T
The goal of this clinical trial is to compare the PCR rate between Total Neoadjuvant Treatment ±Immunotherapy in high risk locally advanced rectal cancer. The main questions it aims to answer are: * The PCR rate between the two groups * The 3years DFS between the two groups * Chemoradiotherapy and immunotherapy toxicit
| Condition(s) | Rectal Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | The goal of this clinical trial is to compare the PCR rate between Total Neoadjuvant Treatment ±Immunotherapy in high risk locally advanced rectal cancer. The main questions it aims to answer are: * The PCR rate between the two groups * The 3years DFS between the two groups * Chemoradiotherapy and immunotherapy toxicity * Postoperative complications Participants will receive total neoadjuvant treatment ±immunotherapy followed by surgery. Researchers will compare neoadjuvant treatment ±immunotherapy to see the PCR rate. |
| Who can participate | Inclusion Criteria: 1. \>18，\<75 years old 2. ECOG score 0-1 3. colorectal adenocarcinoma confirmed by pathology 4. The distance between the lower margin of the tumor and the anal margin is ≤12cm or the distance between the anorectal ring (ARJ) is ≤8cm 5. The initial local MRI stage was T4b, or mrN2, or positive MRF, or positive EMVI, or lateral lymph node metastasis (mrLLND+) 6. No evidence of distant metastasis 7. No history of pelvic radiotherapy 8. No history of rectal cancer surgery or chemotherapy 9. Systemic infections that do not require antibiotic treatment 10. Not associated with immune system diseases 11. Blood routine: ANC\>1.5 cells/mm3, HGB\>9.0g /dL, PLT\>800,000/mm3 12. Blood biochemistry: total bilirubin ≤1.5xULN, AST≤2.5xULN, ALT≤2.5xULN; 13. Serum creatinine ≤1.5 times t |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Peking University Cancer Hospital & Institute |
| Locations | Beijing, China |
| Start date | 2023-03-29 |
| NCT ID | NCT06229041 |
| Official listing | https://clinicaltrials.gov/study/NCT06229041 |