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Recruiting Phase 2 NCT07478731

Neoadjuvant SHR-1701 Plus Chemoradiotherapy for Locally Advanced Rectal Cancer

Trial Parameters

Condition CRC (Colorectal Cancer)
Sponsor Hong Qiu
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 48
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-12-20
Completion 2027-12-31
Interventions
SHR-1701 neoadjuvant

Brief Summary

The goal of this clinical trial is to learn if SHR-1701 combine with chemoradiotherapy works to treat severe CRC. Participants will take: Induction: SHR-1701 combined with CAPOX for one cycle. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy/5F). Consolidation: SHR-1701 combined with CAPOX for five cycles, after which the subjects undergo TME surgery.

Eligibility Criteria

Inclusion Criteria: * 1: Sign the informed consent form and voluntarily participate in this study 2: Age 18-75 3: Pathologically confirmed rectal adenocarcinoma(At least meet any of the following criteria:cT3-4、cN2、EMVI+、MRF+) 4: pMMR or MSS/MSI-L rectal adenocarcinoma 5: The distance from tumor edge to the anal verge 6: Expect to complete R0 resection 7: Patients can swallow pills 8: ECOG PS 0-1 9: Patients has not received any anti-tumor treatment before, including surgery, radiotherapy, chemotherapy, targeting therapy and immunotherapy 10: Plan to complete surgery after neoadjuvant therapy 11: There is contraindication to surgery 12: Main organ function efficient, including blood routine examination, blood biochemical examination, coagulation function 13: Female subjects with reproductive capacity are required to undergo a serum pregnancy test 72 hours before starting the administration of the test drug, and the result must be negative. During the trial period and for at least 3 mon

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