RecruitingNot ApplicableNCT06550921
Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma
Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma: A Multicenter, Prospective, Phase II Study
Sponsor
Sun Yat-sen University
Enrollment
60 participants
Start Date
Aug 1, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
Ablation has been an effective approach for treating intrathoracic metastases. However, for hepatocellular carcinoma with oligometastasis, ablation of metastases remains relatively unexplored.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria10
- diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases 20;
- presence of 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 Lenvatinib and PD-1 inhibitor as the first-line systemic therapy for a minimum of 3 months before study 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);
- 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 Criteria7
- recurrent HCC;
- advanced HCC Lenvatinib and PD-1 inhibitor treated with as second systemic therapy;
- 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.
Interventions
PROCEDUREablation of oligometastasis
The oligometastasis of hepatocellular carcinoma are ablation completely by ablation (including microwave ablation, radiofrequency ablation, and cryoablation)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06550921
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