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NOT YET RECRUITING
NCT07837362
PHASE2

SCRT Combined With CAPOX and PD-1/CTLA4 Antibody for Early-stage Low Rectal Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

The study evaluates the combination of immunotherapy of PD-1/ CTLA4 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1/ CTLA4 antibody, finally receive the local excision(TEM) or total mesorectal excision (TME). The rate of complete response (cCR+pCR), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.

Official title: The Combination of PD-1/CTLA4 Antibody and Neoadjuvant Short-course Radiotherapy in Early-stage Low Rectal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2026-09-01

Completion Date

2028-12-31

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

RADIATION

Shor-course radiotherapy

Shor-course radiotherapy: 25Gy/5Fx

DRUG

PD-1/CTLA4 Antibody

Iparomlimab and Tuvonralimab, 5mg/kg, d1 q3w

DRUG

Capecitabine

Capecitabine: 1000mg/m2 d1-14 q3w

DRUG

Oxaliplatin

130mg/m2 d1 q3w

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China