Multimodal ablation with Tislelizumab, lenvatinib and TACE for unresectable primary liver cancer

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

This trial will test whether combining multimodal ablation with Tislelizumab (a PD‑1 antibody), lenvatinib, and TACE helps people with unresectable primary liver cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 17 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy, Tislelizumab, lenvatinib
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06794073 on ClinicalTrials.gov

What this trial studies

This is a prospective, single‑arm, single‑center study treating patients who have unresectable primary hepatocellular carcinoma with a combination of transarterial chemoembolization (TACE), multimodal thermal ablation, the PD‑1 antibody Tislelizumab, and the oral VEGF inhibitor lenvatinib. Patients meeting CNLC stage IIb–IIIa with measurable target lesions (largest >5 cm), ECOG 0–1, and Child‑Pugh score ≤7 will receive the combined local and systemic regimen at Zhongshan Hospital. The study will compare immune markers and clinical outcomes before and after treatment to characterize biological response and safety. Safety, tumor control and potential conversion to resectability will be recorded as key outcomes.

Who should consider this trial

Good fit: Adults 18–80 with clinically or pathologically confirmed hepatocellular carcinoma judged unresectable (CNLC IIb–IIIa), having untreated, radiologically measurable target lesions (largest >5 cm), ECOG 0–1, and Child‑Pugh score ≤7 are the intended participants.

Not a fit: Patients with Child‑Pugh class C liver dysfunction, main portal or hepatic vein tumor thrombus, extensive metastatic disease with expected survival under 3 months, severe major organ dysfunction, recent variceal bleeding, or other active malignancies are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this combined local and systemic approach could improve tumor control, extend survival, and potentially downstage some patients to become eligible for surgery.

How similar studies have performed: Some prior studies combining TACE or ablation with targeted therapy and PD‑1 inhibitors have shown promising signals, but this exact multimodal combination remains relatively novel and less extensively tested.

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. 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.

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: zhiping Yan, M.D

Conditions: Carcinoma, Hepatocellular, Neoplasms, Glandular and Epithelial, Adenocarcinoma, Digestive System Neoplasms, Liver Neoplasms, Multimodal, Tislelizumab, lenvatinib