A Prospective Multi-centered Randomized Controlled Trial on Fruquintinib in Combination With HAIC in the Treatment of Liver Metastatic Colorectal Cancer After Failure of Second-line Systematic Therapy

NCT05511051 | Unknown Phase 2

• 1 other identifier: HMPL-013-N1-CRC102
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 3

Brief Summary

The current study is to investigate the safety and efficacy of fruquintinib combined with HAIC in patients with advanced colorectal liver metastases who have failed second-line systemic standard treatment, in order to provide more survival opportunities for the second progression of advanced colorectal liver metastases.

Conditions

Colorectal Cancer

Keywords

Third-line

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  every two months after end of treatment (EOT) observation period at 30 days after the last medication every two months after end of treatment (EOT) observation period at 30 days after the last medication every two months after end of treatment (EOT) observation period at 30 days after the last medication

  from randomization until death due to any cause, assessed up to 2 year

Secondary Outcomes (3)

• Progress-free Survival

  from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year

• Objective Response Rate

  from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year

• Safety and tolerance evaluated by incidence, severity and outcomes of AEs

  from first dose to within 30 days after the last dose

Study Arms (2)

Fruquintinib + HAIC

EXPERIMENTAL

Fruquintinib: 5 mg orally once daily for 21 days on followed by 7 days off (q4w); HAIC: oxaliplatin 100 mg/m2, leucovorin calcium 200 mg/m2, fluorouracil 2000 mg/m2 24-hour drip, q4w, 2 cycles; HAIC treatment was administered during fruquintinib rest; HAIC was discontinued 1 day before surgery, on the day of completion of surgery, and 5 days after surgery;

Drug: Fruquintinib; Drug: HAIC

Fruquintinib

ACTIVE COMPARATOR

Fruquintinib: 5 mg orally once daily for 21 days on followed by 7 days off (q4w);

Drug: Fruquintinib

Interventions

Fruquintinib DRUG

Fruquintinib

Fruquintinib; Fruquintinib + HAIC

HAIC DRUG

HAIC

Fruquintinib + HAIC

Eligibility Criteria

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

You may qualify if:

• Fully understand the study and voluntarily sign the informed consent form;
• Age ≥ 18 years;
• Patients with unresectable colorectal liver metastases who have failed standard second-line systemic therapy, who have not previously received HAIC therapy, and have not received third-line standard targeted agents (regorafenib or fruquintinib or trifluridine tipiracil (TAS-102);
• Definition of liver metastases: at least 1 measurable liver metastasis lesion (based on RECIST 1.1); if the liver metastases are single, the tumor is \> 5 cm; if multiple tumors, it needs to be greater than or equal to 4, of which at least 1 exceeds 3 cm;
• PFS \> 4 months from last dose of oxaliplatin with FOLFOX regimen
• Child-Pugh classification of liver function: A;
• ECOG performance status 0-1, and no deterioration within 7 days;
• BMI ≥ 18;
• Expected survival ≥ 3 months;
• Vital organs function in accordance with the following requirements (any blood components and cell growth factors are not allowed within 14 days before enrollment):
• Absolute neutrophil count ≥ 1.5 × 109/L and white blood cells ≥ 4.0 × 109/L;
• Platelets ≥ 100 × 109/L;
• Hemoglobin ≥ 90 g/L;
• Total bilirubin TBIL ≤ 1.5 times ULN;
• ALT and AST ≤ 5 times ULN;

You may not qualify if:

• Unable to comply with the study protocol or study procedures;
• Pregnant or breastfeeding women;
• Any factor affecting oral administration;
• Evidence of central nervous system metastases;
• Concurrent with any of the following: uncontrolled hypertension, coronary artery disease, arrhythmia, and heart failure;
• Alcohol or drug abuse within 4 weeks after the last clinical trial;
• Previous VEGFR inhibition therapy;
• Uncontrolled severe concurrent infection resulting in disability;
• Proteinuria ≥ 2 + (1.0 g/24 h);
• Evidence or history of bleeding tendency within 2 months prior to enrollment, regardless of seriousness;
• Arterial/venous thromboembolic events, such as cerebrovascular accidents (including transient ischemic attack), within 12 months before the first treatment;
• Acute myocardial infarction, acute coronary syndrome or CABG within 6 months before the first treatment;
• Fractures or wounds that have not been cured for a long time;
• coagulopathy, bleeding tendency or receiving anticoagulant therapy;
• Inactivated vaccines within 4 weeks prior to enrollment or possible during the study;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Hutchison Medipharma Limited: collaborator

Study Sites (3)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Dalian Medial University Affiliated Second Hospital

Dalian, China

NOT YET RECRUITING

People's Hospital of Inner Mongolia

Hohhot, China

NOT YET RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

HMPL-013

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Interventional Therapy Department

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 22, 2022
• Study Start: February 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: December 31, 2024
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)