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The Efficacy and Safety of Donafenib Plus PD-1/L1 Monoclonal Antibodies Plus TACE) or HAIC as First-line Treatment for Unresectable Hepatocellular Carcinoma A Multi-center, Retrospective Clinical Study
Sponsor: Shanghai Zhongshan Hospital
Summary
This is a multicenter, retrospective study planned to enroll patients with unresectable hepatocellular carcinoma (uHCC) who received first-line donafenib combined with an anti-PD-1/L1 monoclonal antibody and either TACE or HAIC at 8 sites between June 1, 2021 and November 30, 2024. The study consists of two cohorts: Cohort A consists of patients who received donafenib + PD-1/L1 inhibitor + TACE, and Cohort B consists of patients who received donafenib + PD-1/L1 inhibitor + HAIC, with a planned enrollment of 200 patients per cohort. Relevant data will be collected to evaluate the efficacy and safety of donafenib combined with an anti-PD-1/L1 monoclonal antibody and either TACE or HAIC in the treatment of uHCC in real-world clinical practice.
Official title: The Efficacy and Safety of Donafenib Plus PD-1/L1 Monoclonal Antibodies Plus Transarterial Chemoembolization (TACE) or Hepatic Arterial Infusion Chemotherapy (HAIC) as First-line Treatment for Unresectable Hepatocellular carcinomaA Multicenter, Retrospective Clinical Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
400
Start Date
2026-07-31
Completion Date
2028-07-31
Last Updated
2026-07-24
Healthy Volunteers
No
Conditions
Interventions
Donafeinib
Donafenib: 200mg Bid, or follow medical order
Transcatheter arterial chemoembolization
Follow medical order
PD-1 / PD-L1 monoclonal antibody
Follow Drug instructions or medical order
Hepatic Artery Infusion Chemotherapy
Follow medical orders
Locations (8)
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Zhong Shan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Yunnan Cancer Hospital
Kunming, Yunan, China