Status:
RECRUITING
Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Advanced Hepatocellular Carcinoma
Lung Cancer
Eligibility:
All Genders
18-80 years
Brief Summary
Ablation has been an effective therapy in treating intrathoracic metastases. However, for hepatocellular carcinoma with pulmonary oligometastasis, ablation of metastases remains relatively unexplored ...
Detailed Description
Systemic therapy is the standard treatment for advanced hepatocellular carcinoma (HCC) with metastasis. However, metastases with limited number (oligometastasis) can represent a subtype and transition...
Eligibility Criteria
Inclusion Criteria:
- diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
- presence of pulmonary oligometastasis, the metastases found within three month of HCC diagnosis;
- metastases with limited five sites and no more two organs involved, with a maximum diameter of ≤5cm;
- receipt of first-line systemic therapy for minimum of 3 months before ablation, with controlled intrahepatic tumors and no progression of metastases. Controlled intrahepatic tumors were defined as those showing a partial or stable response according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST);
- undergone locoregional treatments, including transarterial artery chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) were included;
- classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- no history of other malignancies.
- life expectancy more than 3 months;
- agreed to participated in this clinical trial;
- Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.
Exclusion Criteria:
- intermediate HCC;
- age < 18 years or > 75 years;
- advanced HCC with more than five metastases;
- no response to Lenvatinib;
- metastases size > 5 cm;
- life expectancy less than 3 months.
Key Trial Info
Start Date :
October 4 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT06644430
Start Date
October 4 2024
End Date
December 30 2025
Last Update
December 3 2024
Active Locations (1)
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1
Chinese PLA General hospital
Beijing, Beijing Municipality, China, 100853