Gecacitinib Combined With Donafenib and PD-1 Inhibitor: Subjects were enrolled and started receiving treatment with Gecacitinib (100mg, Bid, po) for 7 consecutive days; thereafter, they were treated with PD-1 antibody (Q3W, iv) and Donafenib (200mg, Bid, po), counting the day of infusion of PD-1 monoclonal antibodies as C1D1, with each cycle lasting 3 weeks. Subsequent treatments involved administering Gecacitinib for 1 week before each infusion of PD-1.
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age and gender: \>18 years old and≤75 years old, both men and women.
2. All subjects must have Hepatocellular Carcinoma confirmed by pathological or clinical diagnosis.
3. Patients with viable and measurable target lesion per RECIST 1.1.
4. Patients with unresectable hepatocellular carcinoma (uHCC) who experienced disease progression after first-line therapy containing immune checkpoint inhibitors.
5. Patients who are expected to live more than 3 months.
9.ECOG PS 0-1. 10.Child-Pugh ≤7.
Exclusion Criteria:
1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma confirmed by histology or cytology.
2. History of malignant tumor, excluding the following cases:
1. Malignant tumor that was curatively treated more than 5 years prior to study entry and has not recurred since then;
2. 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.
3. Diffuse tumor lesion.
4. Preexisting or history of hepatic encephalopathy, hepatorenal syndrome or liver transplantation.
5. Clinically uncontrolled ascites or pleural effusion.
6. Received treatment with a JAK inhibitor previously .
7. 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.
Primary outcome measure(s)
ORR — From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years Evaluation of tumor burden based on mRECIST criteria
Trial sites (1)
Facility
City
Region
Status
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Tianjin Municipality
More Tianjin Medical University Cancer Institute and Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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