Actively Recruiting

Age: 18Years - 80Years
All Genders
ID06644430

Ablation of Pulmonary Oligometastasis Combined With Systemic Therapy Compared to Systemic Therapy Alone for Advanced Hepatocellular Carcinoma: A Multicenter Retrospective Study

Led by Sun Yat-sen University · Updated on 2024-12-03

470

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the use of ablation combined with systemic therapy for treating advanced hepatocellular carcinoma (HCC) with pulmonary oligometastases. Pulmonary oligometastases represent a stage between localized and widespread disease. While ablation has been effective for intrathoracic metastases from various cancers, its role specifically in HCC with lung oligometastases is still being evaluated. This multicenter retrospective study aims to provide clinical evidence on this treatment approach compared to systemic therapy alone. Participants receive either ablation of pulmonary metastases using image-guided techniques such as microwave ablation, radiofrequency ablation, or cryoablation under CT guidance combined with systemic therapy, or systemic therapy alone following treatment instructions. Ablation targets complete destruction of lung metastases. All participants have already received first-line systemic therapy and may have undergone locoregional treatments like transarterial chemoembolization or hepatic arterial infusion chemotherapy. During the study, researchers will monitor participants for progression-free survival over 12 months as the primary outcome. Secondary outcomes include overall survival at 24 months and objective response rate at 12 months. Participants will be followed with clinical assessments to evaluate tumor control and treatment effects. The study includes adults aged 18 to 80 years with controlled intrahepatic tumors and limited metastatic sites, aiming to understand the benefits and risks of adding ablation to standard systemic therapy in this population.

CONDITIONS

Brief Title

Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of primary hepatocellular carcinoma confirmed histologically or clinically according to American Association for the Study of Liver Diseases criteria
  • Presence of pulmonary oligometastasis found within three months of HCC diagnosis
  • Metastases limited to five sites or fewer and no more than two organs involved, with maximum diameter of 5 cm or less
  • Received first-line systemic therapy for at least 3 months before ablation, with controlled intrahepatic tumors and no progression of metastases
  • Underwent locoregional treatments including transarterial chemoembolization or hepatic arterial infusion chemotherapy
  • Classified as Child-Pugh class A or B and Eastern Cooperative Oncology Group performance status of 0 or 1
  • No history of other malignancies
  • Life expectancy more than 3 months
  • Agreed to participate in this clinical trial
  • Blood counts and liver and kidney function within specified limits
Not Eligible

You will not qualify if you...

  • Intermediate hepatocellular carcinoma
  • Age younger than 18 years or older than 75 years
  • Advanced hepatocellular carcinoma with more than five metastases
  • No response to Lenvatinib treatment
  • Metastases larger than 5 cm
  • Life expectancy less than 3 months

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Ablation and Systemic Therapy

Duration - At least 3 months of systemic therapy before ablation, followed by ongoing treatment duration as per clinical care

Participants undergo image-guided ablation of pulmonary oligometastases combined with systemic therapy according to treatment instructions.

Visits as required for ablation procedure and systemic therapy administration

Monitoring

Duration - Up to 12 months

Participants are observed for progression-free survival and other outcomes following ablation and systemic therapy.

Regular follow-up visits depending on clinical practice

Trial Site Locations

Total: 1 location

1

Chinese PLA General hospital

Beijing, Beijing Municipality, China, 100853

Actively Recruiting

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Research Team

Q

Qunfang Zhou, MD

F

Feng Duan, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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