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
Recruiting now · Not applicable
Conditions studied: Carcinoma, Hepatocellular, Neoplasms, Glandular and Epithelial, Adenocarcinoma, Digestive System Neoplasms, Liver Neoplasms
In brief
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.
Key facts
- Study ID
- NCT06794073
- Run by
- Shanghai Zhongshan Hospital
- People needed
- 17
- Starts
- 2026-01-31
- Expected to finish
- 2027-08-31
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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