Health TrialsbyHealthPanel

Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma

ConditionsHepatocellular CarcinomaAdjuvant Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Donafenib

    Drug

    Donafenib 100 mg twice daily (BID)

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: Arm A (Donafenib)Experimental treatment 1 intervention
Group B: Arm B (active surveillance)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

One year recurrence-free survival (RFS) rate

The proportion from randomization to 1 year without recurrence.

Time frame
1 year

Secondary outcomes

1

Recurrence-Free Survival (RFS )

The time from randomization to disease recurrence, or death from any cause (whichever occurs first).

Time frame
6 years
2

Recurrence-Free Survival rate (RFS rate)

The proportion from randomization to 2 years, 3 years or 5 years without recurrence.

Time frame
5 years
3

Overall Survival (OS)

The time from randomization to death from any cause.

Time frame
6 years

Other outcomes

Sponsors and contacts

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

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov
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