Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-31 @ 2:14 PM
Study NCT ID:
NCT05406206
Status:
UNKNOWN
Last Update Posted:
2022-06-06
First Post:
2022-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatic Arterial Infusion Chemotherapy With Fruquintinib for Colorectal Cancer Liver Metastases As Third-line Therapy
Sponsor:
Peking University Cancer Hospital & Institute
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: