Gecacitinib Combined With Donafenib and PD-1 Inhibitor as Immune Rechallenge Therapy for Unresectable Hepatocellular Carcinoma

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL ·

Keywords

ClinConnect Summary

This Phase II study is testing a new three-drug approach for people with unresectable hepatocellular carcinoma (liver cancer that cannot be removed by surgery) who have not responded to prior immunotherapy. The combination includes Gecacitinib (a JAK inhibitor), Donafenib (a targeted cancer drug), and a PD-1 immune therapy. The main goal is to see how often tumors shrink or disappear (tumor response) using standard imaging, with overall survival, time before the cancer grows, and safety also being watched over up to about 3 years.

Who can join? Adults roughly 18 to 75 years old (up to 80) who have confirmed unresectable HCC that progressed after first-line immunotherapy and have at least one measurable tumor, good overall health, and reasonably good liver function. Key exclusions include certain other liver cancer types, very diffuse tumors, prior JAK inhibitor treatment, and certain serious health conditions. If eligible, you’ll go through a 3‑week cycle of treatment that combines oral Gecacitinib and Donafenib with an IV PD-1 inhibitor; Gecacitinib is given around the time of the PD-1 treatment. The trial is being run at Tianjin Medical University Cancer Institute and Hospital in China, led by Wei Zhang. It is not recruiting yet, with an estimated start in September 2025 and expected completion around 2028, and safety will be carefully monitored by a data safety monitoring committee.

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Eligibility criteria