Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University
About this trial
Ablation has been an effective approach for treating intrathoracic metastases. However, for hepatocellular carcinoma with oligometastasis, ablation of metastases remains relatively unexplored.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- ablation of oligometastasis
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Sun Yat-sen University
Lead sponsor
Chinese PLA General Hospital
Collaborator
Source ClinicalTrials.gov