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RECRUITING
NCT07150949
PHASE2

Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

SERRAC is a prospective, multicentre, randomized phase II trial. 138 LARC (T3-4/N+M0, distance from anal verge ≤10cm) patients will be treated with neoadjuvant therapy and assigned to Group A and Group B (1:1). Group 1 receives LCRT (50Gy/25Fx) followed by 3 cycles of CAPOX.Group 2 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. The COX2 inhibitor celecoxib 200 mg was started orally twice a day during chemotherapy until the end of neoadjuvant treatment.TME surgery is scheduled after TNT while a watch and wait (W\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.

Official title: A Prospective Randomized Phase II Trial of Long-Course Chemoradiotherapy or Short-Course Radiotherapy Combined With CAPOX, PD-1 Antibody, and a COX-2 Inhibitor for Microsatellite Stable Locally Advanced Rectal Cancer (SERRAC)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2025-08-28

Completion Date

2028-08-31

Last Updated

2025-09-02

Healthy Volunteers

No

Interventions

RADIATION

Long-course radiotherapy

Long-course radiation: 50Gy/25Fx

DRUG

Oxaliplatin

Oxaliplatin: 130mg/m2 d1 q3w

DRUG

Capecitabine

Xeloda

DRUG

Celecoxib

celecoxib 200 mg orally twice a day

RADIATION

Short-course radiotherapy

Short-course radiotherapy: 25Gy/5Fx

DRUG

Serplulimab

Serplulimab 300mg, d1, q3w

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China