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Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC

ConditionsHepatocellular CarcinomaMicrowave AblationDonafenibRecurrent Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

This study intends to evaluate the efficacy and safety of low-dose adjuvant donafenib after thermal ablation for early recurrent HCC within Milan criteria.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

were aged 18-75 years;

had recurrent HCC (RHCC) diagnosed by imaging studies, the first or the second RHCC;

RHCC met the Milan criteria, namely single RHCC lesion less than 5 cm in diameter or no more than 3 tumors (each ≤3 cm in diameter);

the early RHCC (recurrent time <1 year)

Disqualifiers

were under 18 years or over 75 years of age;

primary HCC;

recurrent HCC beyond Milan criteria;

RHCC with metastasis or macrovascular tumor thrombus

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thermal ablation

    Procedure/Surgery

    Thermal ablation of tumors

  • Donafenib

    Drug

    Donafenib ( 100 mg，bid)

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Thermal ablationExperimental treatment 1 intervention
Group B: Microwave ablation plus DonafenibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Tumor-free survival rate

Progression was defined as progressive disease after thermal ablation by independent radiologic review according to mRECIST or death from any cause

Time frame
24 months

Secondary outcomes

1

Overall survival (OS)

OS is the length of time from the date of ablation until death from any cause.

Time frame
36 months
2

Adverse events

Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Chinese PLA General Hospital

Collaborator

Source ClinicalTrials.gov
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