Actively Recruiting
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
Led by Shanghai Zhongshan Hospital · Updated on 2026-05-11
17
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years, any gender
- Clinically or pathologically confirmed hepatocellular carcinoma (HCC)
- CNLC stage IIb-IIIa and deemed unresectable after multidisciplinary evaluation
- Radiologically evaluable, untreated target lesions for ablation with largest tumor diameter greater than 5 cm
- No prior systemic chemotherapy, targeted therapy, or immunotherapy for HCC, or stable/progressive disease after such treatment
- ECOG performance status 0-1 and expected survival greater than 3 months
- Child-Pugh score 7 or less
You will not qualify if you...
- Child-Pugh class C liver dysfunction
- Tumor thrombus in main portal vein or hepatic vein
- Extensive metastatic disease with expected survival less than 3 months
- Severe dysfunction of major organs (liver, kidney, heart, lung, brain)
- History of esophageal or gastric variceal bleeding within the past month
- History of other malignancies
- Anti-tumor therapy within less than 1 month prior to enrollment
- Active infection including HBV co-infection with high viral load, HCV requiring 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 largest liver lesion diameter and number of liver lesions greater than 12)
- Any other condition deemed unsuitable by investigators that may affect participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
zhiping Yan, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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