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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Fruquintinib is a capsule in the form of 1mg and 5mg, once a day, 3 week on/1 week off.
HAIC is a locoregional therapy for colorectal cancer liver metastasis. Oxaliplatin 85 mg/m\*2 + 5-FU 2000 mg/m\*2, Q4W
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGProgression-Free Survival (PFS)
Progression-free survival is defined as the time from the start of treatment HAIC until the first documentation of disease progression or death due to any cause, whichever occurs first.
Time frame: Up to 2 years
Objective Response Rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Time frame: Up to 2 years
Duration of Response (DoR)
Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Time frame: Up to 2 years
Overall Survival (OS)
Overall survival is defined as the time from the start of treatment with HAIC until death due to any cause.
Time frame: Up to 2 years
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