NCT05262959

A Single Center Study of Donafenib Combined With PD-1 + TACE in the First-line Treatment of aHCC

A Single Center Study of Donafenib Combined With Programmed Cell Death-1 （PD-1） + Transarterial Chemoembolization (TACE) in the First-line Treatment of Advanced Hepatocellular Carcinoma (aHCC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is expected to recruit 30 patients with unresectable HCC who will be treated with Donafenib combined with PD-1 + TACE. During the study period, the tumor efficacy and resectability will be evaluated by imaging examination every 6 weeks. Patients with successful transformation can choose hepatectomy or observation. During the study, safety evaluation and effectiveness evaluation will be carried out.

Conditions

• Donafenib

Interventions

Type	Name	Description
DRUG	Donafenib, PD-1	Eligible subjects will receive Donafenib combined with PD-1 and TACE. Donafenib will be taken orally twice a day, 0.1mg each time.PD-1 will be used intravenously every 3 weeks.
PROCEDURE	TACE	TACE will be performed by the investigator based on the patient's tumor status.

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-04-30
• Completion: 2024-05-30
• First posted: 2022-03-02
• Last updated: 2024-08-13

Locations

1 site across 1 country: China