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Recruiting

NCT Number: NCT06581315

Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

Changzhen Shang, MD

CONTACT

[email protected]

+86-20-3407 0701

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Donafenib

Drug

Donafenib 100 mg twice daily (BID)

Other names: Zepsun

Primary outcomes

  1. One year recurrence-free survival (RFS) rate

    Time frame: 1 year

    The proportion from randomization to 1 year without recurrence.

Secondary outcomes

  1. Recurrence-Free Survival (RFS )

    Time frame: 6 years

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

  2. Recurrence-Free Survival rate (RFS rate)

    Time frame: 5 years

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

  3. Overall Survival (OS)

    Time frame: 6 years

    The time from randomization to death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Changzhen Shang, MD

CONTACT

[email protected]

+86-20-3407 0701

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2032
First posted
Sep 3, 2024
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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