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

NCT07300488 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: MB07133-2025-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HCC

Outcome Measures

Primary Outcomes (1)

• 9-month Overall Survival (OS) rate

  9-month Overall Survival (OS) rate：The proportion of the total number of subjects who survived for 9 months from randomization.

  Up to 12 months

Secondary Outcomes (1)

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

  Up to 12 months

Study Arms (2)

Pracytarabine

EXPERIMENTAL

Treatment with 1200 mg/m²/d Pracytarabine

Drug: Pracytarabine

regorafenib

ACTIVE COMPARATOR

Treatment with regorafenib 160 mg once daily

Drug: regorafenib

Interventions

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.

Pracytarabine

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.

regorafenib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Nanjing Tianyinshan Hospital

Nanjing, Jiangsu, 211100, China

Location

MeSH Terms

Interventions

regorafenib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 23, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)