Actively Recruiting
Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer
Led by Fudan University · Updated on 2025-09-04
138
Participants Needed
5
Research Sites
178 weeks
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
A
Anyang Tumor Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years, regardless of gender.
- Pathologically confirmed rectal adenocarcinoma.
- Tumor located �3C=10 cm from the anal verge.
- Baseline stage T3-4 and/or N+ (locally advanced disease).
- No evidence of distant metastasis.
- Microsatellite stability (MSS) or proficient mismatch repair (pMMR).
- Karnofsky Performance Status (KPS) �3E=70.
- No prior chemotherapy or any other anticancer therapy before enrollment.
- No prior immunotherapy.
- Able to comply with study protocol requirements throughout the study period.
- Signed written informed consent obtained prior to study participation.
You will not qualify if you...
- Pregnant or lactating women.
- History of other malignant diseases within the past 5 years, excluding cured skin cancer and cervical carcinoma in situ.
- History of uncontrolled epilepsy, central nervous system diseases, or mental disorders affecting consent or compliance.
- Clinically significant heart disease, including symptomatic coronary heart disease, congestive heart failure NYHA class II or worse, severe arrhythmias requiring treatment, or myocardial infarction within past 12 months.
- Need for immunosuppressive therapy for organ transplantation or long-term corticosteroid therapy.
- Autoimmune diseases.
- Severe, uncontrolled, recurrent infections or other severe uncontrolled concurrent diseases.
- Blood and biochemical parameters outside specified limits (hemoglobin <90 g/L, ANC <1.5x10^9/L, platelets <100x10^9/L, ALT/AST >2.5x ULN, ALP >2.5x ULN, bilirubin >1.5x ULN, creatinine >1x ULN, albumin <30 g/L).
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- History of hypersensitivity to any study medication components.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China, 350000
Actively Recruiting
2
Anyang Tumor Hospital
Anyang, Henan, China, 455100
Actively Recruiting
3
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China, 250014
Actively Recruiting
4
Yunnan Cancer Hospital
Kunming, China, 650118
Actively Recruiting
5
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
D
Dawei Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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