NCT07300488Active, not recruitingPhase 2/3
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 · Last updated 31 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 9 Dec 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Xi'an Xintong Pharmaceutical Research Co.,Ltd.
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07300488
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 60
- From 1 Sept 2025 to the primary completion date, 28 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of liver or other organ transplantation.
- Has participated in another clinical study within 4 weeks prior to the first dose.
- History of bleeding event due to esophageal and/or gastric varices within 3 months prior to the first dose of study treatment.
Other illness
- Has a known history of, or any evidence of CNS metastases.
Other
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- Clinically symptomatic or recurrently drained pleural effusion, pericardial effusion, or ascites.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing Tianyinshan Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.