Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07724951

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Donafeinib

Donafenib: 200mg Bid, or follow medical order

PROCEDURE

Transcatheter arterial chemoembolization

Follow medical order

DRUG

PD-1 / PD-L1 monoclonal antibody

Follow Drug instructions or medical order

PROCEDURE

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