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

NCT05406206 | Unknown Phase 2

• 1 other identifier: Fru-HAIC-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Colorectal Carcinoma; Liver Metastasis Colon Cancer

Keywords

Hepatic Arterial Infusion Chemotherapy; HAIC; Fruquintinib

Outcome Measures

Primary Outcomes (1)

• Progression-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.

  Up to 2 years

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  Up to 2 years

• Duration of Response (DoR)

  Up to 2 years

• Overall Survival (OS)

  Up to 2 years

Study Arms (1)

HAIC combined with Fruquintinib

EXPERIMENTAL

HAIC with fruquintinib until progression. Fruquintinib should be administrated within 1 week after HAIC.

Drug: Fruquintinib; Procedure: Hepatic Arterial Infusion Chemotherapy

Interventions

Fruquintinib DRUG

Fruquintinib is a capsule in the form of 1mg and 5mg, once a day, 3 week on/1 week off.

Also known as: HMPL-013

HAIC combined with Fruquintinib

Hepatic Arterial Infusion Chemotherapy PROCEDURE

HAIC is a locoregional therapy for colorectal cancer liver metastasis. Oxaliplatin 85 mg/m\*2 + 5-FU 2000 mg/m\*2, Q4W

Also known as: HAIC

HAIC combined with Fruquintinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age ≥ 18 years and ≤75, at the time of study entry.
• Histologically or cytologically documented advanced colorectal carcinoma with unresectable liver metastasis (existence of extrahepatic metastasis is acceptable).
• Previously received 2 lines of standard chemotherapy, including 5-FU, oxaliplatin, and irinotecan.
• Subjects must have at least one measurable lesion per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
• Estimated life expectancy of ≥12 weeks.
• Adequate organ functions verified by laboratory tests within 7 days before the first intervention, including bone marrow, liver and kidney function, and coagulation function
• Female subjects of childbearing potential who are sexually active with a nonsterilized male partner must use an acceptable method of contraception from screening, and must agree to continue using such precautions for 90 days after the final dose of investigational product.
• Written and signed informed consent.

You may not qualify if:

• ANC\<1.5×10\*9/L, PLT\<80×10\*9/L, or Hb\<9g/dL; no blood infusion within 2 weeks.
• TBil\>2.5 × ULN.
• AST or ALT\>5 × ULN.
• Serum Cr\>1.5 × ULN, or CrCl\<50 ml/min (calculated by Cockcroft-Gault equation)
• APTT or PT\> 1.5 × ULN.
• Clinically significant electrolyte abnormalities determined by investigators.
• Proteinuria ≥ 2+ (1.0g/24hr).
• Hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg
• Active gastrointestinal ulceration, ulcerative colitis, or gastrointestinal bleeding; potential gastrointestinal bleeding or perforation determined by investigators.
• History of arterial thrombosis or deep venous thrombosis within 6 months before enrollment; evidence of hemorrhagic tendency or receiving anticoagulant therapy within 2 months before enrollment.
• Stroke or transient cerebral ischemia occurred within 12 months before enrollment.
• History of cardiovascular disease within 6 months before enrollment, including congestive heart failure (NYHA grade\>2), acute myocardial ischemia, severe/unstable angina or CABG; or LVEF\<50%.
• Uncontrollable malignant ascites, pleural effusion, or pericardial effusion (determined by investigators).
• Previous treated with VEGFR inhibitors.
• Other malignant tumors in the past 5 years, except skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

HMPL-013

Central Study Contacts

Xu Zhu, Master

CONTACT

+86-13501146178; drzhuxu@163.com

Aiwei Feng, MD

CONTACT

+86-18643411808; ivyfeng_1026@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 6, 2022
• Study Start: February 25, 2022
• Primary Completion: July 31, 2023
• Study Completion: October 31, 2024
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)