Fruquintinib treatment for advanced liver cancer after immunotherapy
Fruquintinib in Patients With Unresectable Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors : A Single-arm, Phase II Study
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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | sintilimab, fruquintinib, fuquinitinib, chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06446154 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with unresectable, locally advanced, or metastatic HCC who have previously received immune checkpoint inhibitors.
Not a fit: Patients with a history of HIV or organ allografts may not benefit from this study.
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 performed: Previous studies have shown promising results with similar approaches, particularly in colorectal cancer, suggesting potential for success in this context.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- Sun Yat-sen university cancer center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Ming Shi
- Email: shiming@sysu.edu.cn
- Phone: 020-87343115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.