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Hepatic Arterial Infusion Chemotherapy With Fruquintinib for Colorectal Cancer Liver Metastases As Third-line Therapy

Liver Metastasis Colon Cancer Clinical Trial

Official title:
A Phase II Study of Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Fruquintinib as Third-line Therapy for Patients With Unresectable Colorectal Cancer Liver Metastases

Clinical Trial Summary

Fruquintinib (HMPL-013) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor xenografts. Combined with hepatic arterial infusion chemotherapy (HAIC), this study is conducted to assess the efficacy and safety of this regimen in patients with unresectable colorectal cancer liver metastases as the third-line therapy.

Clinical Trial Description

This will be a single-arm, open-label, phase II study. This study will be divided into 2 stages: dose exploration and dose expansion. In the dose exploration stage, "3+3 dose escalation" design will be applied to determined the maximum tolerated dose (MTD) of fruquintinib for next stage: Cohort A: HAIC + fruquintinib 3mg QD, 3 weeks on/1 week off (3w/1w). Cohort B: HAIC + fruquintinib 4mg QD, 3w/1w. Cohort C: HAIC + fruquintinib 5mg QD, 3w/1w. All subjects of this study will be permitted to continue therapy with only safety monitoring and assessments for progression, if the product is well tolerated and the subject has stable disease or better. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05406206
Study type Interventional
Source Beijing Cancer Hospital
Contact Xu Zhu, Master
Phone +86-13501146178
Email drzhuxu@163.com
Status Recruiting
Phase Phase 2
Start date February 25, 2022
Completion date October 31, 2024
View Details
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