NCT07230314

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

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.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Efficacy evaluation: The first efficacy evaluation is conducted 6 weeks (± 7 days) after the first administration, and every 6 weeks (± 7 days) thereafter. Imaging examinations include: CT or MRI of the brain, chest, abdomen (including pelvic cavity) (all are enhanced, unless contrast agents are contraindicated, plain scan can be used as a substitute). Safety evaluation: Conducted on a weekly basis, objective indicators are obtained through examination, and subjective indicators are obtained through adverse events reported by patients.

Conditions

• Unresectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-30
• Primary completion: 2026-11-30
• Completion: 2027-11-30
• First posted: 2025-11-17
• Last updated: 2025-11-17