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
Carcinoma, HepatocellularNeoplasms, Glandular and EpithelialAdenocarcinomaDigestive System NeoplasmsLiver Neoplasms
Investigational drug(s) / intervention(s)
Multimodal Thermal Therapy
Multimodal Thermal Therapy: The high-burden tumor is identified as the target lesion for treatment. A pre-treatment biopsy of the target lesion is performed to obtain tumor tissue. Multimodal ablation therapy of the target lesion is conducted under CT guidance. The treatment procedure follows the tumor ablation protocol using the multimodal therapy radiofrequency temperature-controlled mode.
Study 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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 18-80 years, regardless of gender.
2. Clinically or pathologically confirmed HCC.
3. CNLC stage IIb-IIIa, deemed unresectable after multidisciplinary evaluation.
4. Having radiologically evaluable, untreated target lesions for ablation, with the largest diameter of the target tumor \>5 cm.
5. 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..
6. ECOG PS 0-1 and an expected survival \>3 months.
7. Child-Pugh score ≤7.
Exclusion Criteria:
1. Child-Pugh class C liver dysfunction.
2. Tumor thrombus in the main portal vein or hepatic vein.
3. Extensive metastatic disease with an expected survival \<3 months.
4. Severe dysfunction of major organs (liver, kidney, heart, lung, or brain).
5. History of esophageal/gastric variceal bleeding within the past month.
6. History of other malignancies.
7. Last anti-tumor therapy (e.g., radiotherapy, systemic chemotherapy, or local treatment) within \<1 month.
8. Active infection; HBV co-infection (HBV DNA ≥2000 IU/mL or ≥10⁴ copies/mL unless reduced by one log after antiviral therapy); HCV co-infection requiring guideline-directed antiviral treatment; HIV infection; or biliary tract inflammation.
9. History of organ transplantation or hepatic encephalopathy.
10. Uncorrectable coagulation disorders.
11. Refractory massive ascites, pleural effusion, or cachexia.
12. Pregnancy, impaired consciousness, or inability to comply with treatment.
13. High tumor burden (sum of the largest liver lesion diameter and number of liver lesions \>12).
14. Any other condition deemed unsuitable by investigators that may affect study participation.
Primary outcome measure(s)
Objective response rate (ORR) according to RECIST 1.1 and mRECIST — Follow-up for 12 months, with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively. Refers to the proportion of patients whose tumors shrink to a certain extent and maintain that response for a specified period, including cases of Complete Response (CR) and Partial Response (PR). Tumor objective response is assessed using RECIST 1.1 and mRECIST criteria. At baseline, subjects must have measurable tumor lesions. According to the efficacy evaluation criteria, the outcomes are classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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