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RECRUITING
NCT05555888
PHASE2

The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

The study evaluates the combination of immunotherapy of PD-1 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 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: A Prospective Phase II Trial of Immunotherapy Combined With Short-course Radiotherapy in Early Low Rectal Cancer

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2022-12-12

Completion Date

2025-05-01

Last Updated

2025-01-15

Healthy Volunteers

No

Interventions

DRUG

PD-1 antibody

PD-1 antibody (Toripalimab): 240mg d1 q3w

DRUG

Capecitabine

Capecitabine: 1000mg/m2 d1-14 q3w

DRUG

Oxaliplatin

Oxaliplatin: 130mg/m2 d1 q3w

RADIATION

Short-course radiotherapy

Shor-course radiotherapy: 25Gy/5Fx

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China