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TRIP-FAST: Fruquintinib Plus Tislelizumab and CAPOX for Neoadjuvant Treatment of Rectal Cancer
NCT07888309Phase 2
Key facts
- Status
- Recruiting
- Start
- Sep 2025
- Primary completion
- Sep 2027
- Countries
- 1
- Sponsor
- Ruijin Hospital
- Drugs
- fruquintinib
- Conditions
- rectal cancer
01
Overview
Phase 2, randomised trial of fruquintinib in rectal cancer (2 arms), sponsored by Ruijin Hospital. Primary endpoint: Pathological Complete Response. Started Sep 2025; status: recruiting.
02
Design
2 arms- Study design
- Randomized
Experimental Arm
Short-Course Radiotherapy followed by Fruquintinib, Tislelizumab, and CAPOX
Active Comparator Arm
Short-Course Radiotherapy followed by Tislelizumab, and CAPOX
03
Who it enrols
Adults aged 18-75 with previously untreated, histologically confirmed locally advanced low rectal adenocarcinoma, ECOG PS 0-1, and adequate organ function. Excludes patients with active autoimmune diseases, severe infections, uncontrolled cardiac diseases, or history of other malignancies.
04
Endpoints
Primary
Pathological Complete Response
Secondary
Event-Free Survival
Overall Survival
R0 resection rate
Objective Response Rate
Minimal Residual Disease status
Proportion of participants achieving organ preservation via Watch-and-Wait
Rate of local regrowth during Watch-and-Wait surveillance
Relapse-free survival in Watch-and-Wait participants
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