Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06581315

Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-09-03

204

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants underwent radical resection of hepatocellular carcinoma 4 weeks before randomization
  • High risk of recurrence based on tumor characteristics
  • No prior anti-tumor therapy before surgery except preoperative TACE, traditional Chinese medicine, or interferon therapy
  • Child-Pugh Class A liver function status
  • ECOG Performance Status of 0 or 1
  • CT or MRI confirms no recurrence or metastasis at least 4 weeks after surgery
  • Expected survival time of at least 3 months
Not Eligible

You will not qualify if you...

  • Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma and hepatocellular carcinoma
  • Evidence of residual tumor or history of spontaneous tumor rupture
  • Recurrent hepatocellular carcinoma
  • Prior liver transplantation
  • Prior anti-tumor therapy for hepatocellular carcinoma, including sorafenib, other molecular therapies, anti-PD-1 antibody, immunotherapies, or FOLFOX chemotherapy
  • Alpha-fetoprotein (AFP) levels not returning to normal 4 weeks after surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Guangzhou, Guangdong, China, 510120

Actively Recruiting

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Research Team

C

Changzhen Shang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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