Combination treatment for advanced liver cancer with FGF19 overexpression

Is this trial a fit for you?

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

What this trial studies

This study investigates the safety and efficacy of a combination treatment using ABSK-011, a selective FGFR4 inhibitor, and ABSK043, a PD-1/PD-L1 inhibitor, in patients with unresectable or metastatic hepatocellular carcinoma (HCC) that overexpresses FGF19. Patients who have previously undergone systemic therapy will receive these treatments until disease progression. The study aims to determine the effectiveness of this combination therapy in improving patient outcomes compared to existing treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with HCC confirmed by pathological histology or cytology, or meeting the clinical diagnostic criteria for HCC as the AASLD or Guidelines for the diagnosis and treatment of primary liver cancer (China).
2. Progression of disease confirmed by imaging after receiving at least one line of systemic therapy
3. The central laboratory test report for FGF19 overexpression positive.
4. ECOG performance status of 0 or 1;
5. Adequate organ and marrow function defined by study-specified laboratory tests;

Exclusion Criteria:

1. Has received prior therapy with FGFR4 or pan-FGFR inhibitors;
2. Hypersensitivity for any constituent of ABSK-011 or ABSK043;
3. Past or current hepatic encephalopathy; patients with known untreated or inadequately controlled central nervous system metastases that have not been effectively managed with treatment
4. have other malignant tumors that are currently in a progressive stage or require effective treatment
5. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)

Where it's running

• Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Hao Feng, Ph.D.,MD — Shanghai Jiao Tong University school of medicine affiliate Renji Hospital
• Study coordinator: Hao Feng, Ph.D.,MD
• Email: surgeonfeng@live.com
• Phone: +8615000901110

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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.