NCT06794073 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Carcinoma, Hepatocellular |
| Study Type | INTERVENTIONAL |
| Enrollment | 17 participants |
| Start Date | 2026-01-31 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 17 participants in total. It began in 2026-01-31 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06794073 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Carcinoma, Hepatocellular. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06794073 currently recruiting?
Yes, NCT06794073 is actively recruiting participants. Contact the research team at yan.zhiping@zs-hospital.sh.cn for enrollment information.
Where is the NCT06794073 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06794073 clinical trial?
NCT06794073 is sponsored by Shanghai Zhongshan Hospital. The trial plans to enroll 17 participants.