NCT04948034

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

Status unknown Phase 2 Last updated 27 August 2021

What this trial tests

Phase 2 trial testing Stereotactic Ablative Radiotherapy (SABR) in Metastatic Colorectal Cancer in 68 participants. Status unknown.

Timeline

23 August 2021

Primary endpoint
31 December 2022

31 December 2023

Quick facts

Lead sponsor	Fudan University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	68
Start date	23 August 2021
Primary completion	31 December 2022
Estimated completion	31 December 2023
Sites	1 location across China

Drugs / interventions tested

• Stereotactic Ablative Radiotherapy (SABR)
• Fruquintinib — full drug profile →
• Tislelizumab (TISLELIZUMAB) — full drug profile →

Conditions studied

• Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →

Sponsor

Fudan University

Who can join

18 and older, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Molecular mechanisms targeting drug-resistance and metastasis in colorectal cancer: Updates and beyond.
   Al Bitar S, El-Sabban M, Doughan S, Abou-Kheir W. · · 2023 · cited 53× · PMID 36998426 · DOI 10.3748/wjg.v29.i9.1395
2. Evaluation of Fruquintinib in the Continuum of Care of Patients with Colorectal Cancer.
   Lavacchi D, Roviello G, Guidolin A, Romano S, et al · · 2023 · cited 10× · PMID 36982913 · DOI 10.3390/ijms24065840
3. Efficacy and safety of radiotherapy combined with anti-angiogenic therapy and immune checkpoint inhibitors in MSS/pMMR metastatic colorectal cancer.
   Zhai M, Zhang Z, Wang H, Ren J, et al · · 2024 · cited 9× · PMID 38112050 · DOI 10.1002/cam4.6820
4. RIFLE: a Phase II trial of stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer.
   Wang K, Chen Y, Zhang Z, Wu R, et al · · 2023 · cited 7× · PMID 37842200 · DOI 10.1093/gastro/goad063
5. The Interplay between Anti-Angiogenics and Immunotherapy in Colorectal Cancer.
   Maiorano BA, Parisi A, Maiello E, Ciardiello D. · · 2022 · cited 7× · PMID 36294987 · DOI 10.3390/life12101552
6. Combination immunotherapy for colorectal cancer: Clinical applications, rationale, challenges, and future perspectives.
   Fei J, Cai C, Wu W, Shen H, et al · · 2026 · PMID 41950929 · DOI 10.1016/j.xcrm.2026.102728
7. Breaching the immune-cold barrier in pMMR/MSS metastatic colorectal cancer: emerging strategies beyond standard care.
   Kang W, Zhang Z, Li W, Zhang Q, et al · · 2026 · PMID 41909713 · DOI 10.3389/fimmu.2026.1773002