Clinical trial · Interventional
Efficacy and Safety of Pracytarabine Versus Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma
Randomized, Controlled, Open-Label, Multicenter Phase Ⅱ/Ⅲ Seamless Adaptive Design Registration Clinical Trial of Pracytarabine Versus Regorafenib for Advanced Hepatocellular Carcinoma After Failure of Targeted Drugs and Immune Checkpoint Inhibitors or Dual Immune Checkpoint Inhibitors Therapy
- 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)
This is a Phase 2/3 study evaluating the efficacy and safety of Pracytarabine versus regorafenib in patients with advanced hepatocellular carcinoma (HCC) who have experienced treatment failure with standard systemic therapies involving targeted drugs and immune checkpoint inhibitors, or dual immune checkpoint inhibitors.
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 |
|---|---|---|---|
| HCC | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pracytarabine | Drug | — | UNRESOLVED |
| regorafenib | Drug | Regorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pracytarabine
- description
- Treatment with 1200 mg/m²/d Pracytarabine
- interventionNames
- Drug: Pracytarabine
- type
- ACTIVE_COMPARATOR
- label
- regorafenib
- description
- Treatment with regorafenib 160 mg once daily
- interventionNames
- Drug: regorafenib
Primary outcomes (1)
- measure
- 9-month Overall Survival (OS) rate
- timeFrame
- Up to 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18-75 years, regardless of gender. 2. Diagnosed with HCC either by histopathological and/or cytological examination meeting pathological diagnostic criteria, or in line with the clinical diagnostic criteria of the aforementioned guidelines. 3. Unresectable or metastatic HCC, and have experienced treatment failure with targeted drugs and immune checkpoint inhibitors. 4. Child-Pugh liver function score: Class A/B (≤7 points). 5. Expected survival time ≥ 3 months. 6. ECOG performance status 0 or 1. 7. Barcelona Clinic Liver Cancer (BCLC) stage B or C. 8. No severe involvement of the portal vein, and no invasion of the hepatic vein, superior vena cava, or inferior vena cava. Exclusion Criteria: 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC. 2. Previous history of liver or other organ transplantation. 3. Has participated in another clinical study within 4 weeks prior to the first dose. 4. Has a known history of, or any evidence of CNS metastases. 5. Clinically symptomatic or recurrently drained pleural effusion, pericardial effusion, or ascites. 6. History of bleeding event due to esophageal and/or gastric varices within 3 months prior to the first dose of study treatment.
References
Publications (0)
Data not yet available