Status:
NOT_YET_RECRUITING
Gecacitinib Combined With Donafenib and PD-1 Inhibitor as Immune Rechallenge Therapy for Unresectable Hepatocellular Carcinoma
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Gecacitinib Combined With Donafenib and PD-1 Inhibitor as Immune Rechallenge Therapy for Unresectable Hepatocellular Carcinoma
Detailed Description
Jak inhibitors have already demonstrated the ability to reverse T-cell exhaustion in the treatment of Hodgkin lymphoma. Gecacitinib is a Jak inhibitor that has been approved for the treatment of bone ...
Eligibility Criteria
Inclusion
- Age and gender: \>18 years old and≤75 years old, both men and women.
- All subjects must have Hepatocellular Carcinoma confirmed by pathological or clinical diagnosis.
- Patients with viable and measurable target lesion per RECIST 1.1.
- Patients with unresectable hepatocellular carcinoma (uHCC) who experienced disease progression after first-line therapy containing immune checkpoint inhibitors.
- Patients who are expected to live more than 3 months.
- ECOG PS 0-1. 10.Child-Pugh ≤7.
Exclusion
- Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma confirmed by histology or cytology.
- History of malignant tumor, excluding the following cases:
- Malignant tumor that was curatively treated more than 5 years prior to study entry and has not recurred since then;
- Successful radical resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, preinvasive cervix carcinoma, and other preinvasive cancers.
- Diffuse tumor lesion.
- Preexisting or history of hepatic encephalopathy, hepatorenal syndrome or liver transplantation.
- Clinically uncontrolled ascites or pleural effusion.
- Received treatment with a JAK inhibitor previously .
- Clinically severe gastrointestinal bleeding within 6 months of the start of treatment or any life-threatening bleeding events within 3 months of the start of treatment.
Key Trial Info
Start Date :
September 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT07157306
Start Date
September 10 2025
End Date
January 1 2028
Last Update
September 5 2025
Active Locations (1)
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1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060