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NCT06550921Recruiting

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

Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma: A Multicenter, Prospective, Phase II Study

Source: ClinicalTrials.gov · Last updated 13 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
8 Aug 2024
Start date
1 Aug 2024
Primary completion date
1 Aug 2026
Lead sponsor
Sun Yat-sen University
NCT number
NCT06550921

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 1 Aug 2024 to the primary completion date, 1 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • advanced HCC Lenvatinib and PD-1 inhibitor treated with as second systemic therapy;

Age

  • age \< 18 years or \> 75 years;

Other

  • recurrent HCC;
  • advanced HCC with more than five metastases;
  • no response to Lenvatinib;
  • metastases size \> 5 cm;
  • life expectancy less than 3 months.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Chinese PLA General Hospital
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BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.