NCT07057089 Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer (Neo-Field I)
| NCT ID | NCT07057089 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hebei Medical University Fourth Hospital |
| Condition | Locally Advanced Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2028-03-01 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
The purpose of this study is to explore the efficacy and safety of involved-field radiotherapy-TNT combined with PD-1 inhibitors in pMMR locally advanced rectal cancer.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years old, male or female; 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 3. Pathologic diagnosis of adenocarcinoma of the rectum, definite pMMR type; 4. Clinical staging of T3-4NanyM0 or T1-2N+M0 (based on AJCC 8th edition staging criteria); 5. The lower margin of the primary tumor is located below the peritoneal reflex or the lower margin of the tumor is ≤10 cm from the anal verge; 6. Pre-enrollment laboratory indicators meet the following indicator ranges： 1)Blood: absolute neutrophils ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥90g/L; 2)Liver and kidney function: ALT/AST ≤ 2.5 x ULN, total bilirubin ≤ 1.5 x ULN, creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60mL/min (Cockcroft-Gault formula)； 3)Coagulation: INR ≤ 1.5, APTT ≤ 1.5 x ULN (for those not receiving anticoagulation)； 7. Women or men of childbearing potential need to agree to use effective contraception during the study and for 6 months after the last treatme
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.