Actively Recruiting
Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma: A Multicenter, Prospective, Phase II Study
Led by Sun Yat-sen University · Updated on 2024-08-13
60
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
C
Chinese PLA General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of ablation combined with lenvatinib and a PD-1 inhibitor for advanced hepatocellular carcinoma (HCC) with oligometastasis. This study explores a subtype of metastatic HCC where there are limited metastases, aiming to evaluate whether removing these metastases can improve survival. The trial is a multicenter, prospective, phase II study focused on the safety and effectiveness of this combined approach. Participants receive a treatment combining ablation of oligometastases using microwave ablation, radiofrequency ablation, or cryoablation, along with systemic therapy using lenvatinib and PD-1 inhibitors. Ablation targets metastases limited to five sites in no more than two organs, each measuring up to 5 cm. Patients must have already received at least 3 months of lenvatinib and PD-1 inhibitor therapy with controlled intrahepatic tumors before ablation. Throughout the study, participants will be monitored for progression-free survival over 24 months as the primary outcome. Additional assessments include overall survival, objective response rate, and adverse events within 12 to 24 months. Researchers will perform regular evaluations to track treatment response and safety, with the total study duration extending to August 2027.
CONDITIONS
Brief Title
Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary hepatocellular carcinoma confirmed histologically or clinically according to the American Association for the Study of Liver Diseases criteria
- Presence of oligometastasis detected within three months of HCC diagnosis
- Metastases limited to five sites and no more than two organs involved, with a maximum diameter of 5 cm
- Received lenvatinib and PD-1 inhibitor as first-line systemic therapy for at least 3 months before ablation, with controlled intrahepatic tumors and no progression of metastases
- Underwent locoregional treatments such as transarterial chemoembolization or hepatic arterial infusion chemotherapy
- Classified as Child-Pugh class A or B and have an ECOG performance status of 0 or 1
- No history of other malignancies
- Life expectancy greater than 3 months
- Agreed to participate in the clinical trial
- Hemameba count ≥3.0 x10^9/L, neutrophils ≥1.5 x10^9/L, hemoglobin ≥10.0 g/L, platelets ≥100 x10^9/L, liver enzymes and bilirubin ≤1.5 times normal, and glomerular filtration rate ≥60 ml/min
You will not qualify if you...
- Recurrent hepatocellular carcinoma
- Advanced HCC treated with lenvatinib and PD-1 inhibitor as second-line systemic therapy
- Age younger than 18 years or older than 75 years
- Advanced HCC with more than five metastases
- No response to lenvatinib
- Metastases larger than 5 cm
- Life expectancy less than 3 months
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 - At least 3 months before ablation plus ablation procedure and ongoing treatment duration as per protocol
Participants receive ablation of oligometastasis combined with lenvatinib and PD-1 inhibitor therapy for advanced hepatocellular carcinoma.
1 baseline visit and multiple follow-up visits during treatment
Trial Site Locations
Total: 1 location
1
Chinese PLA General hospital
Beijing, None Selected, China, 100853
Actively Recruiting
Research Team
Q
Qunfang Zhou, MD
F
Feng Duan, MD
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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