NCT07527026 A Single-arm Phase II Clinical Study of Camrelizumab Combined With Long-course Chemoradiotherapy for Total Neoadjuvant Therapy in Locally Advanced Low pMMR/MSS Rectal Cancer
| NCT ID | NCT07527026 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Chinese PLA General Hospital |
| Condition | Locally Advanced Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2028-02-01 |
Trial Parameters
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Brief Summary
In pMMR/MSS locally advanced rectal cancer, can the innovative "chemo-immunotherapy induction + LCRT + chemo-immunotherapy consolidation" approach significantly improve the complete response rate and create opportunities for organ preservation?
Eligibility Criteria
Inclusion Criteria: * Aged 18-75 years, male or female; Histologically confirmed T3-4 and/or N+ rectal adenocarcinoma (AJCC/UICC TNM staging, 8th edition); Lower margin of the tumor ≤10 cm from the anal verge; Expected to achieve R0 resection; Eastern Cooperative Oncology Group (ECOG) performance status 0-1; Able to swallow tablets normally; No prior anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc.; Planned to undergo surgical treatment after neoadjuvant therapy; No contraindications to surgery; Laboratory tests must meet the following requirements: white blood cell count (WBC) ≥4×10⁹/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count ≥100×10⁹/L; hemoglobin ≥90 g/L; serum total bilirubin ≤1.5× upper limit of normal (ULN); serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN; serum creatinine ≤1.5× ULN or creatinine clearance ≥50 mL/min; international normalized ratio (INR) ≤1.5× ULN; activated partial th
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