Actively Recruiting
Ablation of Pulmonary Oligometastasis Combined With Systemic Therapy Compared to Systemic Therapy Alone for Advanced Hepatocellular Carcinoma: A Multicenter Retrospective Study
Led by Sun Yat-sen University · Updated on 2024-12-03
470
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of ablation combined with systemic therapy for treating advanced hepatocellular carcinoma (HCC) with pulmonary oligometastases. Pulmonary oligometastases represent a stage between localized and widespread disease. While ablation has been effective for intrathoracic metastases from various cancers, its role specifically in HCC with lung oligometastases is still being evaluated. This multicenter retrospective study aims to provide clinical evidence on this treatment approach compared to systemic therapy alone. Participants receive either ablation of pulmonary metastases using image-guided techniques such as microwave ablation, radiofrequency ablation, or cryoablation under CT guidance combined with systemic therapy, or systemic therapy alone following treatment instructions. Ablation targets complete destruction of lung metastases. All participants have already received first-line systemic therapy and may have undergone locoregional treatments like transarterial chemoembolization or hepatic arterial infusion chemotherapy. During the study, researchers will monitor participants for progression-free survival over 12 months as the primary outcome. Secondary outcomes include overall survival at 24 months and objective response rate at 12 months. Participants will be followed with clinical assessments to evaluate tumor control and treatment effects. The study includes adults aged 18 to 80 years with controlled intrahepatic tumors and limited metastatic sites, aiming to understand the benefits and risks of adding ablation to standard systemic therapy in this population.
CONDITIONS
Brief Title
Ablation of Pulmonary Oligometastasis Combined With System 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 American Association for the Study of Liver Diseases criteria
- Presence of pulmonary oligometastasis found within three months of HCC diagnosis
- Metastases limited to five sites or fewer and no more than two organs involved, with maximum diameter of 5 cm or less
- Received first-line systemic therapy for at least 3 months before ablation, with controlled intrahepatic tumors and no progression of metastases
- Underwent locoregional treatments including transarterial chemoembolization or hepatic arterial infusion chemotherapy
- Classified as Child-Pugh class A or B and Eastern Cooperative Oncology Group performance status of 0 or 1
- No history of other malignancies
- Life expectancy more than 3 months
- Agreed to participate in this clinical trial
- Blood counts and liver and kidney function within specified limits
You will not qualify if you...
- Intermediate hepatocellular carcinoma
- Age younger than 18 years or older than 75 years
- Advanced hepatocellular carcinoma with more than five metastases
- No response to Lenvatinib treatment
- 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 of systemic therapy before ablation, followed by ongoing treatment duration as per clinical care
Participants undergo image-guided ablation of pulmonary oligometastases combined with systemic therapy according to treatment instructions.
Visits as required for ablation procedure and systemic therapy administration
Duration - Up to 12 months
Participants are observed for progression-free survival and other outcomes following ablation and systemic therapy.
Regular follow-up visits depending on clinical practice
Trial Site Locations
Total: 1 location
1
Chinese PLA General hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
Q
Qunfang Zhou, MD
F
Feng Duan, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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