Colorectal Neoplasms
Conditions
Brief summary
This study was a phase 2, single-arm, single-center clinical trial in which previously treated patients with unresectable colorectal cancer liver metastases.
Detailed description
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.
Interventions
DRUGFOLFOXIRI-based HAIC+Fuquinitinib
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.
Sponsors
Meng Qiu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 75 years; * Histologically or cytologically confirmed CRLM; * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2; * Prior failure of at least second-line of systemic therapy (fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy regimens, anti-EGFR therapy for RAS wild-type tumors and/or anti-VEGF therapy); * At least one measurable intrahepatic target lesion according to RECIST V1.1 criteria; * Normal major organ function(liver, kidney, heart, and lungs); * Patients with limited extrahepatic metastases (defined as up to 3 metastatic lesions in a single organ system) were eligible for inclusion.
Exclusion criteria
* Previous treatment with transarterial chemoembolization (TACE) or HAIC; prior use of fruquintinib; * A history of another malignancy within 5 years prior to enrollment, except for adequately treated non-melanoma skin cancer or in situ carcinoma, carcinoma in situ of the cervix, or gastrointestinal tumors treated curatively with endoscopic mucosal resection; * Allergy to the study drug; * Severe dysfunction of major organs (liver, kidney, heart, or lungs).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | 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. | ORR is defined as the proportion of patients with the best overall response of CR or PR among all participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall progression-free survival (PFS) | 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. | PFS is defined as the time from the initiation of treatment until disease progression or death. |
| Duration of Response(DoR) | 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. | DoR was defined as time from first occurrence of complete or partial response until date of radiographical disease progression or death, whichever occurred first. |
| Disease control rate(DCR) | 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. | The proportion of patients with a best overall response of achieved complete response, partial response or stable disease. |
| Overall survival (OS) | From date of the first treatment until the date of date of death from any cause, whichever came first, assessed up to 100 months. | OS was defined as the time from study enrollment to death from any cause. |
| Liver-specific PFS | 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. | Liver-specific PFS was defined analogously to PFS, but considering only progression events occurring within the liver. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORMeng Qiu, Professor
West China Hospital
Outcome results
None listed