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RECRUITING
NCT05877573
NA

Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced,High-Risk,MSS Rectal Cancer

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

Summary

This is a single arm, open-label, prospective clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and toripalimab (PD-1 antibody) for locally advanced rectal cancer (LARC) patients with high risk factors. A total of 53patients will be enrolled in this trial to receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery and another 2 cycles of CAPOX chemotherapy. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2023-07-01

Completion Date

2026-08-01

Last Updated

2023-07-05

Healthy Volunteers

No

Interventions

DRUG

Toripalimab

Toripalimab 240mg,d1,q3w

RADIATION

short-term radiotherapy

25Gy/5Fx

DRUG

Oxaliplatin

135mg/m2 d1 q3w

DRUG

Capecitabine

1200mg/m2 d1-14 q3w

Locations (1)

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, China