Clinical trial · Interventional
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
NCT07157306CI-TRIAL-00094627not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gecacitinib Combined With Donafenib and PD-1 Inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- study arm
- description
- The participants in this arm will be treated with combination therapy of Gecacitinib(100mg,Bid,po), Donafenib (200mg,Bid,po), and PD-1(Q3W,iv).
- interventionNames
- Drug: Gecacitinib Combined With Donafenib and PD-1 Inhibitor
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 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
- description
- Evaluation of tumor burden based on mRECIST criteria
Secondary outcomes (4)
- measure
- OS
- timeFrame
- From date of enrollment until the date of death from any cause, assessed up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDMathew D, Marmarelis ME, Foley C, Bauml JM, Ye D, Ghinnagow R, Ngiow SF, Klapholz M, Jun S, Zhang Z, Zorc R, Davis CW, Diehn M, Giles JR, Huang AC, Hwang WT, Zhang NR, Schoenfeld AJ, Carpenter EL, Langer CJ, Wherry EJ, Minn AJ. Combined JAK inhibition and PD-1 immunotherapy for non-small cell lung cancer patients. Science. 2024 Jun 21;384(6702):eadf1329. doi: 10.1126/science.adf1329. Epub 2024 Jun 21. PMID 38900877
- BACKGROUNDZak J, Pratumchai I, Marro BS, Marquardt KL, Zavareh RB, Lairson LL, Oldstone MBA, Varner JA, Hegerova L, Cao Q, Farooq U, Kenkre VP, Bachanova V, Teijaro JR. JAK inhibition enhances checkpoint blockade immunotherapy in patients with Hodgkin lymphoma. Science. 2024 Jun 21;384(6702):eade8520. doi: 10.1126/science.ade8520. Epub 2024 Jun 21. PMID 38900864