RecruitingNCT06644430

Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma

Ablation of Pulmonary Oligometastasis Combined With System Compared System Therapy for Advanced Hepatocellular Carcinoma: a Multicenter Retrospective Study


Sponsor

Sun Yat-sen University

Enrollment

470 participants

Start Date

Oct 4, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria10

  • 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);
  • undergone locoregional treatments, including transarterial artery chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) were included;
  • 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.

Exclusion Criteria6

  • intermediate HCC;
  • age \< 18 years or \> 75 years;
  • advanced HCC with more than five metastases;
  • no response to Lenvatinib;
  • metastases size \> 5 cm;
  • life expectancy less than 3 months.

Interventions

PROCEDUREAblation

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

DRUGsystem therapy

Paticipants received systemic therapy according the instructions.


Locations(1)

Chinese PLA General hospital

Beijing, Beijing Municipality, China

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NCT06644430


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