Clinical Trial

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

Recruiting Phase 2
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Record status
This record was last updated July 29, 2022 (before its estimated July 31, 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2022-03-18.
Status change: Not Yet Recruiting → Recruiting 2022-07-26
Trial Details
NCT Number NCT05300269
Lead Sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions Locally Advanced Rectal Cancer
Enrollment 73 participants
Start Date 2022-07-05
Primary Completion 2024-07-31 (estimated)
Study Completion 2026-10-31 (estimated)
Updated on ClinicalTrials.gov 2022-07-29