RecruitingPhase 2NCT07478731

Neoadjuvant SHR-1701 Plus Chemoradiotherapy for Locally Advanced Rectal Cancer

A Phase II, Prospective, Single Arm Study of Neoadjuvant SHR-1701 Combine With Chemoradiotherapy for Locally Advanced Rectal Cancer


Sponsor

Hong Qiu

Enrollment

48 participants

Start Date

Dec 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a checkpoint inhibitor drug called SHR-1701 to standard chemotherapy and radiation before surgery can improve outcomes for patients with locally advanced rectal cancer — meaning cancer in the rectum that has grown significantly but has not yet spread to distant organs. **You may be eligible if...** - You are between 18 and 75 years old - You have been newly diagnosed with rectal cancer confirmed by pathology - Your cancer meets criteria for being locally advanced (e.g., growing into surrounding tissue or lymph nodes) - You have not received any prior cancer treatment (no surgery, chemo, radiation, or immunotherapy) - You are in good overall health (ECOG score 0–1) - You are able to swallow pills - You plan to have surgery after the treatment course **You may NOT be eligible if...** - You are allergic to the study drugs or similar agents - You have previously received cancer treatment for this diagnosis - You have serious autoimmune, liver, or other major organ conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-1701 neoadjuvant

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.


Locations(1)

Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT07478731


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