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

NCT ID: NCT06794073

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-08-31

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Multimodal Thermal Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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. No prior systemic chemotherapy, targeted therapy, or immunotherapy for HCC, or prior-treated patients with a best response of SD or PD.

5. At least one measurable, untreated lesion eligible for ablation, with the largest target lesion diameter >5 cm.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

zhiping Yan, M.D

Role: CONTACT

yan.zhiping@zs-hospital.sh.cn

+86 13122806500

Other Identifiers

MTT-B2024

Identifier Type: -

Identifier Source: org_study_id