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

NCT07300488 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pracytarabine

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.

DRUG

regorafenib

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

Sponsors & Collaborators

  • Xi'an Xintong Pharmaceutical Research Co.,Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-02-28
Completion
2027-04-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07300488 on ClinicalTrials.gov