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NOT YET RECRUITING
NCT07230314
PHASE2

Sequential Transarterial Chemoembolization (TACE), Stereotactic Body Radiation Therapy (SBRT), and Immune Checkpoint Inhibitors for Unresectable Hepatocellular Carcinoma Treated With Donafenib

Sponsor: Jinling Hospital, China

View on ClinicalTrials.gov

Summary

This study is a single arm, single center, open label clinical trial. Recruit 34 subjects who meet the inclusion criteria and receive hepatic artery chemoembolization (TACE) and stereotactic body radiotherapy (SBRT) combined with immune checkpoint inhibitors and donafenib treatment according to the study plan. The treatment cycle and dosage can be adjusted according to the patient's tolerance. Until disease progression or intolerable toxic reactions occur. Observe the effectiveness and safety indicators during the experimental process.

Official title: Luminate Study: A Single-arm, Single-center, Open-label Clinical Study of Transarterial Chemoembolization (TACE) Plus Stereotactic Body Radiotherapy (SBRT) Combined With PD-1/L1 Inhibitor and Donafenib as First-line Therapy for Unresectable Hepatocellular Carcinoma.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2025-11-30

Completion Date

2027-11-30

Last Updated

2025-11-17

Healthy Volunteers

No

Interventions

DRUG

Donafina

During the treatment, oral administration of Donafenib (0.2g, bid) was consistently administered

DRUG

PD-1/PD-L1 inhibitor

According to the specific drug instructions, Q3W, The maximum usage time is 2 years