This study was a phase 2, single-arm, single-center clinical trial in which previously treated patients with unresectable colorectal cancer liver metastases.
The aim of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy combined with fruquintinib in later treatment for colorectal cancer liver metastases. All patients received FOLFOXIRI-based HAIC chemotherapy and oral fruquintinib. The primary end point was objective response rate (ORR), and the secondary endpoints were disease control rate (DCR), the liver-specific ORR, overall survival (OS), progression-free survival (PFS), liver-specific PFS, duration of response(DoR)and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
All patients received oral fruquintinib at an initial dose of 4 mg once daily from day 1 to day 21 of each 28-day cycle, and FOLFOXIRI-HAIP chemotherapy with Oxaliplatin 85 mg/m² and Leucovorin 400 mg/m² infused via arterial pump over 2 hours on day 1, Irinotecan 150 mg/m² infused via arterial pump over 90 minutes on day 1,and 5-Fluorouracil 2400 mg/m² infused via arterial pump over 46 hours, repeated biweekly until disease progression, patient's refusal, unacceptable toxic effects, or withdrawal of consent.
West China Hospital of Sichuan University
Chengdu, Sichuan, China
objective response rate
ORR is defined as the proportion of patients with the best overall response of CR or PR among all participants.
Time frame: The best evaluation of clinical efficacy from the time of the first initiation of treatment until the patient's disease progression to change of treatment or death, assessed up to 100 months.
overall progression-free survival (PFS)
PFS is defined as the time from the initiation of treatment until disease progression or death.
Time frame: From date of the first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Duration of Response(DoR)
DoR was defined as time from first occurrence of complete or partial response until date of radiographical disease progression or death, whichever occurred first.
Time frame: From date of first occurrence of complete or partial response until date of radiographical disease progression or death, whichever occurred first. the assessed up to 100 months.
Disease control rate(DCR)
The proportion of patients with a best overall response of achieved complete response, partial response or stable disease.
Time frame: From date of the first treatment until the date of date of death from any cause or experiment stopped, whichever came first, assessed up to 100 months.
Overall survival (OS)
OS was defined as the time from study enrollment to death from any cause.
Time frame: From date of the first treatment until the date of date of death from any cause, whichever came first, assessed up to 100 months.
Liver-specific PFS
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Liver-specific PFS was defined analogously to PFS, but considering only progression events occurring within the liver.
Time frame: From date of the first treatment until the date of first documented liver progression or date of death from any cause, whichever came first, assessed up to 100 months.