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

NCT07154316 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2025-09-04

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

LCRT

50Gy/25Fx

RADIATION

SCRT

25Gy/5Fx

DRUG

CAPOX

1000mg/m2 bid d1-14

DRUG

PD-1

300mg d1，q3w

DRUG

Celecoxib

200mg, bid

Sponsors & Collaborators

  • Anyang Tumor Hospital

    collaborator OTHER

  • Fujian Cancer Hospital

    collaborator OTHER_GOV

  • Shandong First Medical University

    collaborator OTHER

  • Yunnan Cancer Hospital

    collaborator OTHER

  • Fudan University

    lead OTHER

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
2025-08-01
Primary Completion
2028-08-01
Completion
2028-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT07154316 on ClinicalTrials.gov