drugset / Trial / NCT05300269

SHR-1701 in Combination With Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer

NCT05300269

Phase 2 Recruiting 73 enrolled Suzhou Suncadia Biopharmaceuticals Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This study will evaluate the efficacy and safety of SHR-1701 combined with radiotherapy and chemotherapy as perioperative treatment for locally advanced rectal cancer. Eligible patients will receive standard chemoradiation with SHR-1701 followed by XELOX combined with SHR-1701. In all subjects, restaging pelvic MRI with chest and abdominal CT will be performed after completion of neoadjuvant treatment to determine resectability and to rule out any evidence of metastases. Subjects who have resectable disease will undergo surgery. Adjuvant XELOX combined with SHR-1701 will be given after surgery.

Timeline

Start
2022-07-05
Primary completion
2024-07-31
Completion
2026-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Retlirafusp alfa Protein / enzyme biologic
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous

Indications

No indication recorded.