NCT06751394

Preoperative Chemoradiotherapy and Toripalimab in Locally Recurrent Rectal Cancer

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Rectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2024-12-27
• Last updated: 2024-12-27

Locations

1 site across 1 country: China