Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma

Recruiting now · Not applicable

Conditions studied: Hepatocellular Carcinoma, Adjuvant Therapy

In brief

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.

Key facts

Study ID

NCT06581315

Run by

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

People needed

204

Starts

2024-08-28

Expected to finish

2032-08-30

Last updated by the study team

2024-09-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sun Yat-sen Memorial Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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