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

NCT06794073 | Not Yet Recruiting

• 1 other identifier: MTT-B2024
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Carcinoma, Hepatocellular; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Digestive System Neoplasms; Liver Neoplasms

Keywords

Multimodal; Tislelizumab; lenvatinib; TACE; unresectable primary liver cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) according to RECIST 1.1 and mRECIST

  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).

  Follow-up for 12 months, with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively.

Secondary Outcomes (3)

• Progression-Free Survival（PFS）

  Follow-up for 12 months,with assessments conducted every 3 months.

• Overall Survival（OS）

  Follow-up for 12 months,with assessments conducted every 3 months.

• Safety and Tolerability

  Follow-up for 12 months, with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively.

Study Arms (1)

Treatment Group

EXPERIMENTAL

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.

Device: Multimodal Thermal Therapy

Interventions

Multimodal Thermal Therapy DEVICE

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.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years, regardless of gender.
• Clinically or pathologically confirmed HCC.
• CNLC stage IIb-IIIa, deemed unresectable after multidisciplinary evaluation.
• No prior systemic chemotherapy, targeted therapy, or immunotherapy for HCC, or prior-treated patients with a best response of SD or PD.
• At least one measurable, untreated lesion eligible for ablation, with the largest target lesion diameter \>5 cm.
• ECOG PS 0-1 and an expected survival \>3 months.
• Child-Pugh score ≤7.

You may not qualify if:

• Child-Pugh class C liver dysfunction.
• Tumor thrombus in the main portal vein or hepatic vein.
• Extensive metastatic disease with an expected survival \<3 months.
• Severe dysfunction of major organs (liver, kidney, heart, lung, or brain).
• History of esophageal/gastric variceal bleeding within the past month.
• History of other malignancies.
• Last anti-tumor therapy (e.g., radiotherapy, systemic chemotherapy, or local treatment) within \<1 month.
• 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.
• History of organ transplantation or hepatic encephalopathy.
• Uncorrectable coagulation disorders.
• Refractory massive ascites, pleural effusion, or cachexia.
• Pregnancy, impaired consciousness, or inability to comply with treatment.
• High tumor burden (sum of the largest liver lesion diameter and number of liver lesions \>12).
• Any other condition deemed unsuitable by investigators that may affect study participation.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Digestive System Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

zhiping Yan, M.D

CONTACT

+86 13122806500; yan.zhiping@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share