Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma

Sun Yat-sen University

Status: Enrolling

Conditions: Hepatocellular Carcinoma; Adjuvant Therapy

Treatments: Drug: Donafenib

Study type: Interventional

Funder types: Other

Identifiers

NCT06581315

SYXKY-2024-666-02

Details and patient eligibility

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.

Enrollment: 204 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

Arm A (Donafenib)

Experimental group

Description:

Participants will receive Donafenib treatment until disease recurrence or unacceptable toxicity or up to 1 years.

Treatment:

Drug: Donafenib

Arm B (active surveillance)

No Intervention group

Description:

Active surveillance of participants.