drugset / Trial / NCT07284992

SCRT VS LCRT Followed by PD-L1 Inhibitor Plus CAPEOX as TNT in Patients With LARC

NCT07284992 ↗

Phase 2 Recruiting 208 enrolled Shandong Provincial Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-09-12
Primary completion
2028-11-30
Completion
2033-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Adebrelimab Monoclonal antibody 20 mg/kg Intravenous
Subject Adebrelimab Monoclonal antibody 1200 mg Intravenous
Background Capecitabine Small molecule 825 mg/m2 Oral
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous

Indications