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

NCT ID: NCT07300488

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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HCC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pracytarabine

Treatment with 1200 mg/m²/d Pracytarabine

Group Type EXPERIMENTAL

Pracytarabine

Intervention Type 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

Treatment with regorafenib 160 mg once daily

Group Type ACTIVE_COMPARATOR

regorafenib

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xi'an Xintong Pharmaceutical Research Co.,Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nanjing Tianyinshan Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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MB07133-2025-01

Identifier Type: -

Identifier Source: org_study_id