Status:
RECRUITING
Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Anyang Tumor Hospital
Fujian Cancer Hospital
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 Oxali...
Eligibility Criteria
Inclusion
- Age 18-75 years, regardless of gender.
- Pathologically confirmed rectal adenocarcinoma.
- Tumor located ≤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) ≥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.
Exclusion
- Pregnant or lactating women.
- Individuals with a history of other malignant diseases within the past 5 years, excluding cured skin cancer and cervical carcinoma in situ.
- Individuals with a history of uncontrolled epilepsy, central nervous system diseases, or mental disorders, where the clinical severity (as judged by the investigator) may impair the ability to sign the informed consent form or affect compliance with oral medication.
- Clinically significant (i.e., active) heart disease, including symptomatic coronary heart disease, congestive heart failure of New York Heart Association (NYHA) class II or worse, severe arrhythmias requiring pharmacological intervention, or a history of myocardial infarction within the past 12 months.
- Individuals requiring immunosuppressive therapy for organ transplantation and those on long-term corticosteroid therapy.
- Individuals with autoimmune diseases.
- Individuals with severe, uncontrolled, recurrent infections or other severe, uncontrolled concurrent diseases.
- Baseline blood routine and biochemical parameters not meeting the following criteria: hemoglobin ≥90 g/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelets ≥100×10⁹/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× upper limit of normal (ULN); alkaline phosphatase (ALP) ≤2.5×ULN; serum total bilirubin \<1.5×ULN; serum creatinine \<1×ULN; serum albumin ≥30 g/L.
- Individuals with known dihydropyrimidine dehydrogenase (DPD) deficiency. Individuals with a history of hypersensitivity to any component of the study medications.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT07154316
Start Date
August 1 2025
End Date
December 30 2028
Last Update
September 4 2025
Active Locations (5)
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1
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China, 350000
2
Anyang Tumor Hospital
Anyang, Henan, China, 455100
3
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China, 250014
4
Yunnan Cancer Hospital
Kunming, China, 650118