Efficacy and Safety of Multimodal Ablation Combined With PD-1 Monoclonal Antibody, Lenvatinib and… (NCT06794073) | Clinical Trial Compass
RecruitingNot Applicable
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
China17 participantsStarted 2026-01-31
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Objective response rate (ORR) according to RECIST 1.1 and mRECIST
Timeframe: Follow-up for 12 months, with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively.
. 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.