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

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07300488

Enrollment

Registered

2025-12-23

Start date

2025-09-01

Completion date

2027-04-30

Last updated

2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCC

Brief summary

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.

Interventions

DRUGPracytarabine

Pracytarabine 1200 mg/m²/d, administered as a continuous intravenous infusion for 7 days (Days 1 to 7), followed by a 21-day treatment-free observation period; each treatment cycle is 4 weeks.

DRUGregorafenib

Regorafenib 160 mg, once daily, administered continuously for 3 weeks followed by 1 week of rest, i.e., each cycle is 4 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
9-month Overall Survival (OS) rate	Up to 12 months	9-month Overall Survival (OS) rate：The proportion of the total number of subjects who survived for 9 months from randomization.

Secondary

Measure	Time frame	Description
Progression-free survival (PFS) assessed by investigator per RECIST v1.1	Up to 12 months	PFS is defined as the time from randomization till the first documented disease progression (Per RECIST v1.1 assessed by the investigator) or death due to any cause, whichever occurs first.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026