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

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.

Timeline

Start

2021-08-23

Primary completion

2022-12-31

Completion

2023-12-31

Publications

• Wang K, Chen Y, Zhang Z, Wu R, Zhou M, Yang W, Wan J, Shen L, Zhang H, Wang Y, Han X, Wang J, Zhang Z, Xia F. RIFLE: a Phase II trial of stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer. Gastroenterol Rep (Oxf). 2023 Oct 11;11:goad063. doi: 10.1093/gastro/goad063. eCollection 2023.

Drugs

Indications