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

NCT07150949 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2025-09-02

No results posted yet for this study

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.

Conditions

  • Locally Advanced Rectal Cancer
  • Neoadjuvant Therapy

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Zhen Zhang, M.D, PH.D · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-28
Primary Completion
2027-08-31
Completion
2028-08-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07150949 on ClinicalTrials.gov