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NOT YET RECRUITING
NCT06751394
PHASE2

Preoperative Chemoradiotherapy and Toripalimab in Locally Recurrent Rectal Cancer

Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

View on ClinicalTrials.gov

Summary

The study is a prospective, single-center, single-arm, phase II clinical trial. Patients with pelvic recurrent rectal cancer aged from 18 to 75 years, Eastern Cooperative Oncology Group performance status of 0-1, will receive 45-50Gy/25Fx irradiation or 30Gy/15Fx reirradiation (history of pelvic radiation). PD-1 inhibitor (Toripalimab) was used throughout the course of induction chemotherapy (before radiation), concurrent chemoradiation and consolidation chemotherapy (after radiation); radical resection was followed by well-experienced surgeons . The primary endpoint was pathological complete response (pCR) rate. Secondary endpoints were R0 resection rate, 3-year progression-free survival, overall survival, pathological tumor regression grade, operation characteristics and incidence of major surgical complications.

Official title: Preoperative Treatment with Radiotherapy and Anti-PD1 for Resectable Recurrent Rectal Cancer (TRACER)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2025-01-01

Completion Date

2028-12-31

Last Updated

2024-12-27

Healthy Volunteers

No

Interventions

DRUG

PD-1 antibody (Toripalimab)

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

DRUG

Capecitabine

Capecitabine:1000mg/m² d1-14 q3w; Capecitabine:825mg/m² on the day of radiotherapy

DRUG

Oxaliplatin

130 mg/m² q3w

DRUG

Irinotecan

200 mg/m² q3w

RADIATION

Radiation

45-50Gy/25Fx or 30Gy/15Fx

PROCEDURE

surgery

The type of surgery will depend on the site of recurrence and the involvement of adjacent structures, which will be determined by the surgeons.

Locations (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China