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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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.