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

Fudan University

Status: Not yet enrolling

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

Treatments: Device: Multimodal Thermal Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06794073

MTT-B2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Treatment Group

Experimental group

Description:

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.

Treatment:

Device: Multimodal Thermal Therapy