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NCT Number: NCT07300488

Efficacy and Safety of Pracytarabine Versus Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HCC

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nanjing Tianyinshan Hospital

Nanjing, Jiangsu, 211100, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-75 years, regardless of gender.
  • 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.
  • Unresectable or metastatic HCC, and have experienced treatment failure with targeted drugs and immune checkpoint inhibitors.
  • Child-Pugh liver function score: Class A/B (≤7 points).
  • Expected survival time ≥ 3 months.
  • ECOG performance status 0 or 1.
  • Barcelona Clinic Liver Cancer (BCLC) stage B or C.
  • No severe involvement of the portal vein, and no invasion of the hepatic vein, superior vena cava, or inferior vena cava.

Exclusion criteria

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  • Previous history of liver or other organ transplantation.
  • Has participated in another clinical study within 4 weeks prior to the first dose.
  • Has a known history of, or any evidence of CNS metastases.
  • Clinically symptomatic or recurrently drained pleural effusion, pericardial effusion, or ascites.
  • History of bleeding event due to esophageal and/or gastric varices within 3 months prior to the first dose of study treatment.

Treatment and study plan

Pracytarabine

Drug

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.

regorafenib

Drug

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

Primary outcomes

  1. 9-month Overall Survival (OS) rate

    Time frame: 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 outcomes

  1. Progression-free survival (PFS) assessed by investigator per RECIST v1.1

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Xi'an Xintong Pharmaceutical Research Co.,Ltd.

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 23, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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