RecruitingPhase 2NCT07154316

Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer

A Randomized Phase II Study of Long-term Chemoradiotherapy or Short-term Radiotherapy Combined With CAPOX, PD-1 Monoclonal Antibody and COX-2 Inhibitors in MSS Type Locally Advanced Rectal Cancer


Sponsor

Fudan University

Enrollment

138 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized phase II trial evaluates the efficacy of long-course chemoradiotherapy (50Gy/25Fx + capecitabine) versus short-course radiotherapy (25Gy/5Fx) combined with CAPOX(Capecitabine and Oxaliplatin), PD-1 inhibitor (serplulimab), and COX-2 inhibitor (celecoxib) in MSS(MicroSatellite Stable) locally advanced rectal cancer, with primary endpoint of complete response rate (pCR+cCR)(Complete Remission) and secondary endpoints including anal preservation rate and 3-year survival outcomes, aiming to elucidate the immunomodulatory effects of triple therapy on tumor microenvironment.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two radiation-based treatment approaches for locally advanced rectal cancer that does not have a specific genetic marker (MSS type). One approach uses long-course chemoradiation, while the other uses short-course radiation followed by chemotherapy plus immunotherapy and a COX-2 inhibitor. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed rectal cancer located within 10 cm of the anal opening - Your cancer has spread to the wall or nearby lymph nodes but not to distant organs - Your cancer is the microsatellite stable (MSS) type - You have not had any prior chemotherapy or anticancer treatment - Your overall physical function is adequate (Karnofsky score 70 or above) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have had another cancer in the past 5 years (except cured skin cancer or cervical in situ) - You have serious heart disease, autoimmune disease, or active uncontrolled infection - You are on long-term steroids or immunosuppressant medications - You have a known deficiency in processing fluorouracil-type drugs (DPD deficiency) 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

RADIATIONLCRT

50Gy/25Fx

RADIATIONSCRT

25Gy/5Fx

DRUGCAPOX

1000mg/m2 bid d1-14

DRUGPD-1

300mg d1,q3w

DRUGCelecoxib

200mg, bid


Locations(5)

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

Anyang Tumor Hospital

Anyang, Henan, China

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Yunnan Cancer Hospital

Kunming, China

Fudan University Shanghai Cancer Center

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT07154316


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