Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06581315

Enrollment

204

Registered

2024-09-03

Start date

2024-08-28

Completion date

2032-08-30

Last updated

2024-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjuvant Therapy, Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, Adjuvant Therapy

Brief summary

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

DRUGDonafenib

Donafenib 100 mg twice daily (BID)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
One year recurrence-free survival (RFS) rate	1 year	The proportion from randomization to 1 year without recurrence.

Secondary

Measure	Time frame	Description
Recurrence-Free Survival (RFS )	6 years	The time from randomization to disease recurrence, or death from any cause (whichever occurs first).
Recurrence-Free Survival rate (RFS rate)	5 years	The proportion from randomization to 2 years, 3 years or 5 years without recurrence.
Overall Survival (OS)	6 years	The time from randomization to death from any cause.

Countries

China

Contacts

Primary ContactChangzhen Shang, MD

shchzh2@mail.sysu.edu.cn+86-20-3407 0701

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026