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Clinical Trials in China / NCT06550921
Recruiting Not applicable

Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma

NCT06550921 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Not applicable
Started
2024-08-01
Last updated
2024-08-13

Condition(s) studied

Advanced Hepatocellular CarcinomaOligometastasisAblationAnti-PD1 AntibodyLenvatinib

Investigational drug(s) / intervention(s)

ablation of oligometastasis

ablation of oligometastasis: The oligometastasis of hepatocellular carcinoma are ablation completely by ablation (including microwave ablation, radiofrequency ablation, and cryoablation)

Study summary

Ablation has been an effective approach for treating intrathoracic metastases. However, for hepatocellular carcinoma with oligometastasis, ablation of metastases remains relatively unexplored.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases 20; 2. presence of oligometastasis, the metastases found within three month of HCC diagnosis; 3. metastases with limited five sites and no more two organs involved, with a maximum diameter of ≤5cm; 4. 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); 5. undergone locoregional treatments, including transarterial artery chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC); 6. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 7. no history of other malignancies. 8. life expectancy more than 3 months; 9. agreed to participated in this clinical trial; 10. 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: 1. recurrent HCC; 2. advanced HCC Lenvatinib and PD-1 inhibitor treated with as second systemic therapy; 3. age \< 18 years or \> 75 years; 4. advanced HCC with more than five metastases; 5. no response to Lenvatinib; 6. metastases size \> 5 cm; 7. life expectancy less than 3 months.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Chinese PLA General hospital Beijing None Selected Recruiting

More Sun Yat-sen University trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06550921 on ClinicalTrials.gov ↗ ← All trials in China