Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma
Recruiting now
Conditions studied: Advanced Hepatocellular Carcinoma, Lung Cancer, Oligometastasis, Ablation, Systemic Therapy
In brief
Ablation has been an effective therapy in treating intrathoracic metastases. However, for hepatocellular carcinoma with pulmonary oligometastasis, ablation of metastases remains relatively unexplored and still needs clinical evidence.
Key facts
- Study ID
- NCT06644430
- Run by
- Sun Yat-sen University
- People needed
- 470
- Starts
- 2024-10-04
- Expected to finish
- 2025-12-30
- Last updated by the study team
- 2024-12-03
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Chinese PLA General hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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