NCT05763927

Neoadjuvant Therapy for Locally Advanced Rectal Cancer With Fruquintinib, Toripalimab and SRT

Prospective Single-arm Phase II Clinical Study of Fruquintinib Combined With Toripalimab and SRT in Neoadjuvant Therapy for Locally Advanced Rectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy and safety of combined fruquintinib、toripalimab and SRT in neoadjuvant therapy for locally advanced rectal cancer.

Detailed description

The aim of this study is to investigate whether combined fruquintinib、toripalimab and SRT can achieve breakthrough efficacy in neoadjuvant therapy for locally advanced rectal cancer, achieving a better pCR rate and better tolerance compared with conventional neoadjuvant therapy for locally advanced rectal cancer.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Fruquintinib	Fruquintinib 5mg 2w on/1w off, 21d/cycle, totally 4 cycle.
DRUG	Toripalimab	Toripalimab 200mg d1, 21d/cycle, totally 4 cycle.
RADIATION	Short-course radiotherapy	25 Gy in 5 fraction, d22-26.
PROCEDURE	TME	Surgical resection of the primary tumour in the rectum, 2-4weeks after the last dose of fruquintinib

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-10-01
• Completion: 2025-04-01
• First posted: 2023-03-10
• Last updated: 2023-03-10

Locations

1 site across 1 country: China