Efficacy and Safety of Multimodal Ablation Combined With PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of Unresectable Primary Hepatocellular Carcinoma: A Single-Arm, Single-Center Clinical Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study is a prospective, single-arm, single-center trial evaluating the efficacy of TACE combined with multimodal ablation, Tislelizumab, and lenvatinib in the treatment of unresectable primary liver cancer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Age 18-80 years, regardless of gender.
• Clinically or pathologically confirmed HCC.
• CNLC stage IIb-IIIa, deemed unresectable after multidisciplinary evaluation.
• Having radiologically evaluable, untreated target lesions for ablation, with the largest diameter of the target tumor \>5 cm.
• Patients who have not undergone systemic chemotherapy, targeted therapy, or immunotherapy for hepatocellular carcinoma, or those who have been evaluated as SD (stable disease) or PD (progressive disease) after treatment..
• ECOG PS 0-1 and an expected survival \>3 months.
• Child-Pugh score ≤7.
Locations
Other Locations
China
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
zhiping Yan, M.D
yan.zhiping@zs-hospital.sh.cn
+86 13122806500
Time Frame
Start Date:2026-01-31
Estimated Completion Date:2027-08-31
Participants
Target number of participants:17
Treatments
Experimental: Treatment Group
The patient will receive induction therapy with tislelizumab and lenvatinib within 14 days after enrollment. Subsequently, within 2-7 days (the exact timing will be determined based on clinical circumstances), they will undergo Multimodal Thermal Therapy (MTT). Following the MTT procedure, on-demand TACE treatment will be administered. Starting from day 7 post-MTT (with the exact timing adjusted according to clinical conditions), the patient will resume tislelizumab and lenvatinib therapy until disease progression, occurrence of intolerable toxicity, or withdrawal of consent.