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

ConditionsAdvanced Hepatocellular CarcinomaOligometastasisAblationAnti-PD1 AntibodyLenvatinib
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • ablation of oligometastasis

    Procedure/Surgery

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

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Ablation-Len-PD-1 inhibitorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free-Survival (PFS)

Progression-Free-Survival (PFS)

Time frame
24 months

Secondary outcomes

1

Overall survival (OS)

OS is the length of time from the date of inclusion until death from any cause.

Time frame
24 months
2

Objective response rate (ORR)

ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.

Time frame
12 months
3

Adverse events

Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Chinese PLA General Hospital

Collaborator

Source ClinicalTrials.gov
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