Status:
RECRUITING
Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Chinese PLA General Hospital
Conditions:
Advanced Hepatocellular Carcinoma
Oligometastasis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Ablation has been an effective approach for treating intrathoracic metastases. However, for hepatocellular carcinoma with 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
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06550921
Start Date
August 1 2024
End Date
August 30 2027
Last Update
August 13 2024
Active Locations (1)
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1
Chinese PLA General hospital
Beijing, None Selected, China, 100853