Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Fruquintinib treatment for advanced liver cancer after immunotherapy

Official title: Fruquintinib in Patients With Unresectable Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors : A Single-arm, Phase II Study

Run by Sun Yat-sen University · NCT06446154 · Data updated 2026-11-12

This study is testing if a new drug called fruquintinib can help people with advanced liver cancer who haven't responded well to previous immunotherapy treatments.

More Hepatocellular Carcinoma trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment36 (estimated)
SponsorSun Yat-sen University
Academic / other
Drugs / interventionssintilimab, fruquintinib, fuquinitinib, chemotherapy
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedDecember 27, 2024
Main results expectedDecember 1, 2025
Study endsJuly 1, 2026
Registry record updatedDecember 31, 2024
Trial IDNCT06446154 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 or older with unresectable, locally advanced, or metastatic HCC who have previously received immune checkpoint inhibitors.

Probably not a fit

Patients with a history of HIV or organ allografts may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial investigates the efficacy and safety of fruquintinib, a tyrosine kinase inhibitor, as a second-line treatment for patients with unresectable hepatocellular carcinoma (HCC) who have previously received immune checkpoint inhibitors. The study aims to improve treatment outcomes for advanced HCC, which currently has limited second-line options. Participants must have measurable disease and meet specific health criteria to qualify for the trial. The trial is conducted at Sun Yat-sen University Cancer Center in Guangzhou, Guangdong.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced liver cancer who have exhausted other therapies.

How similar studies have gone: Previous studies have shown promising results with similar approaches, particularly in colorectal cancer, suggesting potential for success in this context.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* patients aged 18 years or older
* with unresectable, locally advanced, or metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Disease criteria
* who had previously received immune checkpoint inhibitors
* had at least on measurable disease, as defined by Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1) criteria
* had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* had a Child-Pugh liver function score of 7 or less
* had adequate hematologic and organ function (absolute neutrophil count ≥1.2×109/l, platelet count ≥60×109/l, total bilirubin \< 30μmol/l, albumin ≥ 30g/l, aspartate transaminase and alanine transaminase ≤ 5×upper limit of the normal, creatinine clearance rate of ≤ 1.5×upper limit of the normal, and left ventricular ejection ≥ 45%)

Exclusion Criteria:

* history of HIV, organ allograft
* combined with other malignant tumors
* evidence of hepatic decompensation, bleeding diathesis or event
* allergy to the investigational agents or any agent given in association with this trial
* incomplete medical information.

Where it's running

  • Sun Yat-sen university cancer center
    Guangzhou, Guangdong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.