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Recruiting NCT06644430

Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma

— Observational Advanced Hepatocellular Carcinoma Lung Cancer Oligometastasis Ablation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ablation, system therapy.
Who it may be relevant to
Registry conditions: Advanced Hepatocellular Carcinoma, Lung Cancer, Oligometastasis, Ablation. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

Systemic therapy is the standard treatment for advanced hepatocellular carcinoma (HCC) with metastasis. However, metastases with limited number (oligometastasis) can represent a subtype and transition point between localized disease and widespread metastases. Thus, eliminating metastases could be advantageous and beneficial to the prognosis if feasible and permitted. Image-guided ablation therapy, such as microwave ablation (MWA), radiofrequency ablation (RFA), and cryoablation, has attracted great interest as a minimally invasive approach against intrathoracic metastases. Recently, ablation has been used on patients with pulmonary metastases from various cancers. This technique yields high proportions of sustained complete responses and is associated with relatively low morbidity. This multicenter study focuses on the management of ablation of oligometastasis therapy combined with systemic therapy.

Interventions

  • Procedure Ablation
    Ablation including (microwave ablation, radiofrequency ablation, cryoblation), this surgery was conducted under CT guidence. The pulmonary was completely ablated.
  • Drug system therapy
    Paticipants received systemic therapy according the instructions.

Primary outcome measures

  • Progression-Free-Survival [Time frame: 12 months]
Secondary outcome measures (2)
  • Overall survival (OS) [Time frame: 24 months]
  • Objective response rate (ORR) [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Chinese PLA General hospital — Beijing

Identifiers

NCT: NCT06644430 · CHEST-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗