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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: zhiping Yan, M.D
• Email: yan.zhiping@zs-hospital.sh.cn
• Phone: +86 13122806500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.