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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment approach for patients with unresectable primary liver cancer, specifically hepatocellular carcinoma (HCC). This prospective, single-arm, single-center trial investigates the combination of transarterial chemoembolization (TACE), multimodal thermal ablation, and systemic therapies including the PD-1 monoclonal antibody Tislelizumab and the drug lenvatinib. The study aims to assess the effectiveness and safety of this combined treatment and to better understand immune changes before and after therapy in managing primary liver cancer. Participants will begin with induction therapy using Tislelizumab and lenvatinib within 14 days of enrollment. Between 2 and 7 days later, they will undergo multimodal thermal therapy (MTT) guided by CT scans, targeting the main tumor. After MTT, on-demand TACE treatment will be given as needed. From 7 days post-MTT, patients will resume Tislelizumab and lenvatinib treatment until disease progression, intolerable side effects, or withdrawal from the study. Throughout the 12-month follow-up, participants will have regular assessments to monitor tumor response using imaging criteria (RECIST 1.1 and mRECIST) at intervals from 2 weeks to 12 months after treatment. Researchers will also evaluate progression-free survival, overall survival, and safety at scheduled visits every 3 months. This monitoring includes clinical evaluations, immune marker comparisons before and after treatment, and tolerability checks to understand the clinical benefit and risks of this combined therapy approach.
CONDITIONS
Brief 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)
- Liver cancer classified as CNLC stage IIb-IIIa, judged unresectable after specialist evaluation
- Presence of untreated, radiologically measurable target tumor lesions larger than 5 cm
- No prior systemic chemotherapy, targeted therapy, or immunotherapy for HCC, or stable/progressive disease after such treatments
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with expected survival over 3 months
- Child-Pugh liver function score of 7 or less
You will not qualify if you...
- Child-Pugh class C liver dysfunction
- Tumor thrombus in main portal or hepatic vein
- Extensive metastases with expected survival less than 3 months
- Severe dysfunction of major organs including liver, kidney, heart, lung, or brain
- Recent esophageal or gastric variceal bleeding within the past month
- History of other cancers
- Anti-tumor treatments within less than 1 month before enrollment
- Active infections such as HBV with high viral load, hepatitis C needing treatment, HIV infection, or biliary tract inflammation
- History of organ transplantation or hepatic encephalopathy
- Uncorrectable blood clotting disorders
- Severe fluid buildup like refractory ascites or pleural effusion, or severe weight loss (cachexia)
- Pregnancy, impaired consciousness, or inability to follow treatment
- High tumor burden exceeding specified size and number limits
- Any other conditions the investigators consider unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Induction therapy within 14 days after enrollment; MTT within 2-7 days after induction; ongoing systemic therapy from day 7 post-MTT until progression or withdrawal
Participants receive induction therapy with tislelizumab and lenvatinib within 14 days after enrollment, followed by Multimodal Thermal Therapy (MTT) conducted under CT guidance. On-demand TACE treatment is administered after MTT. Starting from day 7 post-MTT, participants resume tislelizumab and lenvatinib therapy until disease progression, intolerable toxicity, or withdrawal.
Multiple visits including initial induction therapy visits, MTT procedure visit, and ongoing treatment visits
Duration - 12 months
Participants are monitored for efficacy and safety with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively. Assessments include objective response rate, progression-free survival, overall survival, and safety.
Visits at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here