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

Phase 2Not Yet RecruitingNCT07157306

Tianjin Medical University Cancer Institute and Hospital35 enrolled

Overview

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

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 marrow fibrosis. This study was designed to evaluate the safety and efficacy of Gecacitinib Combined With Donafenib and PD-1 Inhibitor as Immune Rechallenge Therapy for Unresectable Hepatocellular Carcinoma . Total 35 subjects will be recruited in this study, ORR will be will be used as primary outcome measures, OS, PFS, DCR and safety will be the secondary endpoints.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

Gecacitinib Combined With Donafenib and PD-1 InhibitorDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Outcomes

Primary Outcomes

ORR

Evaluation of tumor burden based on mRECIST criteria

Time frame: 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

Secondary Outcomes

Time frame: From date of enrollment until the date of death from any cause, assessed up to 3 years

PFS

Evaluation of tumor burden based on mRECIST criteria

Time frame: 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

DCR

Evaluation of tumor burden based on mRECIST criteria

Time frame: 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

Incidence of treatment-related adverse events (TRAE)

Number of patients with AE, treatment-related AE (TRAE), serious adverse event (SAE) assessed by CTCAE v5.0

Time frame: From date of enrollment until the date of 30 days after the last treatment according to the protocol, assessed up to 3 years

Central Contacts

Wei Zhang

CONTACT

86-2223340123 Ext. 3090 zhang.wei@tmu.edu.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.