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Recruiting NCT06581315

Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma

No phase Interventional Hepatocellular Carcinoma Adjuvant Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Donafenib.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma, Adjuvant Therapy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Donafenib as Adjuvant Therapy for Postoperative Patients With High-Risk Recurrent Hepatocellular Carcinoma: A Multicenter, Randomized Controlled Study

Overview

This study aims to evaluate the efficacy and safety of donafenib as adjuvant therapy for postoperative patients with high-risk recurrent Hepatocellular Carcinoma. This is a multicenter, randomized controlled study.

Interventions

  • Drug Donafenib
    Donafenib 100 mg twice daily (BID)

Primary outcome measures

  • One year recurrence-free survival (RFS) rate [Time frame: 1 year]
Secondary outcome measures (3)
  • Recurrence-Free Survival (RFS ) [Time frame: 6 years]
  • Recurrence-Free Survival rate (RFS rate) [Time frame: 5 years]
  • Overall Survival (OS) [Time frame: 6 years]

Eligibility criteria

Inclusion criteria

  • Participants underwent radical resection of hepatocellular carcinoma 4 weeks before randomization
  • High Risk of recurrence as assessed by tumor characteristics
  • Without any anti-tumor therapy before surgery, except preoperative TACE therapy, traditional Chinese medicine therapy and interferon therapy
  • Child-Pugh Class A statu
  • ECOG Performance Status of 0 or 1
  • CT/MR confirmed no recurrence or metastasis at ≥4 weeks after surgery
  • Expected survival time of no less than 3 months

Exclusion criteria

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Evidence of residual or a history of spontaneous tumor rupture
  • Recurrent HCC
  • Prior received Liver transplantation
  • Prior anti tumor therapy for treatment of HCC (including sorafenib or any other molecular therapy, anti-PD-1 antibody and other immunotherapies, FOLFOX systemic chemotherapy) is excluded
  • AFP does not return to normal 4 weeks after operation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT06581315 · SYXKY-2024-666-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗