NCT04948034

The Combination of Fruquintinib, Tislelizumab and Stereotactic Ablative Radiotherapy in Metastatic Colorectal Cancer(RIFLE)

A Phase Ⅱ Trial of Multisite Stereotactic Ablative Radiotherapy (SABR) Combined With Fruquintinib and Tislelizumab in Metastatic Colorectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-center, single-arm phase II clinical trial.This study aims to evaluate the safety and tolerability of stereotactic ablative radiotherapy (SABR) in combination with Fruquintinib and Tislelizumab, and to examine the impact of the combination therapy on tumor control, long-term survival and quality of life in patients with Metastatic colorectal cancer. A total of 68 metastatic colorectal cancer patients who have failed the first-line standard treatment, will be recruited and receive multisite SABR(8-12 Gy, 4-5 times) followed by fruquintinib(5mg, qd) and tislelizumab(200mg, q3w) within two weeks from completion.The overall response rate (ORR), disease control rate(DCR), progression-free survival(PFS) and overall survival(OS) will be analyzed.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic Ablative Radiotherapy (SABR)	We plan to irradiate as many metastatic lesions as possible, in the precondition that normal tissues can tolerate. Target dose will be adjusted depending on site of the lesion and organs at risk (BED \> 100Gy). Treatment schedule is once per day and five days per week. Sequence of irradiation for multiple metastases is at the discretion of the investigators based on their experience.
DRUG	Fruquintinib	Starts within two weeks upon SABR completion: 5mg, d1-14, qd; Continued until disease progression, unacceptable toxicity or patient withdrawal.
DRUG	Tislelizumab	Starts within one week upon SABR completion: 200mg, d1, q3w; the dosing will continue for up to two years until disease progression, unacceptable toxicity or patient withdrawal.

Timeline

• Start date: 2021-08-23
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2021-07-01
• Last updated: 2021-08-27

Locations

1 site across 1 country: China