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Recruiting NCT06794073

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

No phase Interventional Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Adenocarcinoma Digestive System Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multimodal Thermal Therapy.
Who it may be relevant to
Registry conditions: Carcinoma, Hepatocellular, Neoplasms, Glandular and Epithelial, Adenocarcinoma, Digestive System Neoplasms. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

This study aims to evaluate the efficacy and safety of multimodal ablation combined with Tislelizumab, lenvatinib, and TACE in the treatment of primary liver cancer. By comparing preoperative and postoperative immune markers, the study seeks to clarify the clinical value of multimodal ablation combined with systemic therapy and TACE in the management of primary liver cancer.

Interventions

  • Device 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.

Primary outcome measures

  • Objective response rate (ORR) according to RECIST 1.1 and mRECIST [Time frame: Follow-up for 12 months, with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively.]
Secondary outcome measures (3)
  • Progression-Free Survival（PFS） [Time frame: Follow-up for 12 months,with assessments conducted every 3 months.]
  • Overall Survival（OS） [Time frame: Follow-up for 12 months,with assessments conducted every 3 months.]
  • Safety and Tolerability [Time frame: Follow-up for 12 months, with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongshan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT06794073 · MTT-B2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗