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Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma

ConditionsAdvanced Hepatocellular CarcinomaLung CancerOligometastasisAblationSystemic Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorSun Yat-sen University

About this trial

Ablation has been an effective therapy in treating intrathoracic metastases. However, for hepatocellular carcinoma with pulmonary oligometastasis, ablation of metastases remains relatively unexplored and still needs clinical evidence.

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;

presence of pulmonary 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 first-line systemic therapy for minimum of 3 months before 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

intermediate HCC;

age < 18 years or > 75 years;

advanced HCC with more than five metastases;

no response to Lenvatinib;

Trial population

Thermal ablation, as a minimal therapy, has been recommended as a favorable therapy for metastases worldwide. However, for advanced hepatocellular carcinoma with pulmonary oligometastasis, the standard of care is system therapy. However, the evidence of ablating the oligometastasis is limited. In this multicenter study, we want to indicate that compared with systemic therapy, patients received thermal ablation of pulmonary oligometastasis plus system therapy showed significantly longer survival. This study will supplement the current situation where system therapy is the standard of care for hepatocellular carcinoma with oligometastasis.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Ablation

    Procedure/Surgery

    Ablation including (microwave ablation, radiofrequency ablation, cryoblation), this surgery was conducted under CT guidence. The pulmonary was completely ablated.

  • system therapy

    Drug

    Paticipants received systemic therapy according the instructions.

Treatment groups

470 Participants
are divided into 2 treatment groups
Group A: Ablation+system group2 interventions
Group B: System group1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free-Survival

Progression was defined as progressive disease by independent radiologic review

Time frame
12 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 is either a complete response or partial response.

Time frame
12 months

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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