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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | sintilimab, fruquintinib, fuquinitinib, chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | December 27, 2024 |
| Main results expected | December 1, 2025 |
| Study ends | July 1, 2026 |
| Registry record updated | December 31, 2024 |
| Trial ID | NCT06446154 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
- Study coordinator: Ming Shi
- Email: shiming@sysu.edu.cn
- Phone: 020-87343115
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Candonilimab with Fruquintinib and Paclitaxel Albumin-Bound as second-line treatment for advanced gastric cancer
This phase 2 trial tests whether adding candonilimab to fruquintinib and nab-paclitaxel helps people with advanced gastric or gastroesophageal junction cancer who progressed after first-line therapy.
-
Ivarmacitinib with Camrelizumab and Fruquintinib in advanced colorectal cancer after prior therapies
This trial tests whether combining ivarmacitinib with camrelizumab and fruquintinib can help patients with metastatic colorectal cancer who have progressed after multiple treatments.
-
Neoadjuvant therapy for locally advanced low rectal cancer: adding fruquintinib to short-course radiotherapy with tislelizumab and CAPOX
This study tests whether adding fruquintinib to short-course radiotherapy plus tislelizumab and CAPOX before surgery helps people with locally advanced low rectal cancer achieve a better tumor response.
-
InstaSure Non-Invasive Finger-Press Test for HCC
This study tests a non-invasive finger-skin test to help identify hepatocellular carcinoma in adults.
-
BGB-B2033 vs Sorafenib or Lenvatinib for advanced liver cancer
This study tests whether the investigational drug BGB-B2033 can help people with advanced hepatocellular carcinoma when given after prior PD-1/PD-L1 therapy, compared with the standard medicines sorafenib or lenvatinib.
-
FAPI-guided radiotherapy with cadonilimab plus chemo for colorectal cancer limited to the peritoneum
Aims to see if adding targeted radiotherapy and cadonilimab immunotherapy to standard second-line chemotherapy helps adults with colorectal cancer that’s spread only to the peritoneum.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.