NCT07157306Not yet recruitingPhase 2
Gecacitinib Combined With Donafenib and PD-1 Inhibitor as Immune Rechallenge Therapy for Unresectable Hepatocellular Carcinoma
Gecacitinib Combined With Donafenib and PD-1 Inhibitor as Second-Line Therapy for Unresectable Hepatocellular Carcinoma Failed in Immunotherapy, A Phase II Prospective Clinical Study
Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 14 Aug 2025
- Start date
- Sept 2025
- Primary completion date
- Jan 2027
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07157306
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 35
- From Sept 2025 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received treatment with a JAK inhibitor previously .
Other illness
- 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.
- Preexisting or history of hepatic encephalopathy, hepatorenal syndrome or liver transplantation.
- 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.
Other
- Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma confirmed by histology or cytology.
- Diffuse tumor lesion.
- Clinically uncontrolled ascites or pleural effusion.
Who the study is looking for
- 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.
- 9.ECOG PS 0-1. 10.Child-Pugh ≤7.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.