NCT07284992 SCRT VS LCRT Followed by PD-L1 Inhibitor Plus CAPEOX as TNT in Patients With LARC
| NCT ID | NCT07284992 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shandong Provincial Hospital |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 208 participants |
| Start Date | 2025-09-12 |
| Primary Completion | 2028-11-30 |
Trial Parameters
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Brief Summary
This is a multicenter, cohort, prospective study to evaluate the efficacy and safety of Adebrelimab combined with radiotherapy and chemotherapy as preoperative neoadjuvant therapy for patients with locally advanced rectal cancer. In the study, all subjects who meet the inclusion criteria will enter the short-term radiotherapy queue and the long-term radiotherapy queue at the ratio of 1:1. The short-term radiotherapy queue plans to receive Adebrelimab combined with short-term radiotherapy (5\*5Gy) and Capox chemotherapy as neoadjuvant therapy. The long-term radiotherapy queue plans to receive Adebrelimab combined with long-term radiotherapy (1.8gy × 25-28 times) and capox chemotherapy as neoadjuvant therapy. The TME surgery will be performed 2-3 weeks after the last neoadjuvant therapy is completed. If the surgery cannot be performed within the time window specified in the plan (such as delayed adverse reactions, etc.), the researcher will conduct the surgery according to the patients' requirements.The actual clinical conditions of the subjects were comprehensively considered.
Eligibility Criteria
Inclusion Criteria: * 1\. sign written informed consent before implementing any test related process; * 2\. Patients diagnosed as rectal adenocarcinoma by primary biopsy and histopathological examination; * 3\. patients with CT stage ≥ T3 or CN stage N1+, M0 or EMVI (+) or MRF (+) or suspected lateral lymph node metastasis (\>5mm) who are judged by imaging and colonoscopy to be operable and need neoadjuvant therapy. * 4\. according to imaging and colonoscopy, the main body of the tumor was located ≤ 10cm from the anal edge; * 5\. patients with tumor mismatch repair/microsatellite instability (MMR/MSI) status as MSS; * 6\. according to the criteria for evaluating the efficacy of solid tumors (RECIST version 1.1), at least one lesion can be measured by imaging; * 7\. the patient has not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc; * 8\. ECoG score: 0-1; * 9\. sufficient organ functio
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