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Active, not recruitingNCT07300488Updated Dec 31, 2025

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

A Phase 2/3 interventional study of Pracytarabine and regorafenib in HCC, sponsored by Xi'an Xintong Pharmaceutical Research Co.,Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-31.

Sponsored by Xi'an Xintong Pharmaceutical Research Co.,Ltd. · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2025, registered Dec 2025).
Phase
Phase 2/3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • HCC
03

In context

Lead sponsor

Xi'an Xintong Pharmaceutical Research Co.,Ltd. is the lead sponsor of 9 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Pracytarabine

    Treatment with 1200 mg/m²/d Pracytarabine

    Drug: Pracytarabine

  • Active comparator
    regorafenib

    Treatment with regorafenib 160 mg once daily

    Drug: regorafenib

Interventions

  • DrugPracytarabine

    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.

  • Drugregorafenib

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

06

What researchers measure

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.

    Time frame: Up to 12 months

Secondary outcomes

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

    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.

    Time frame: Up to 12 months

07

Study locations

1 site
  • Nanjing Tianyinshan Hospital
    Nanjing, Jiangsu 211100, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07300488
Lead sponsor
Xi'an Xintong Pharmaceutical Research Co.,Ltd.
Responsible party
Sponsor
First posted
Dec 23, 2025
Start date
Sep 1, 2025
Primary completion
Feb 28, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Dec 31, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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