Ablation therapy for lung metastases in advanced liver cancer

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

This study tests whether a new treatment combining image-guided ablation therapy with standard care can help people with advanced liver cancer that has spread to the lungs feel better and live longer.

Quick facts

• Study type: Observational
• Enrollment: 470 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: Lenvatinib, chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06644430 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of image-guided ablation therapy combined with systemic therapy for patients with advanced hepatocellular carcinoma (HCC) who have pulmonary oligometastasis. The approach aims to eliminate limited metastases, which may improve patient prognosis. By utilizing techniques such as microwave ablation, radiofrequency ablation, and cryoablation, the study seeks to provide clinical evidence for this minimally invasive treatment. The multicenter design allows for a broader assessment of outcomes across different patient populations.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with primary hepatocellular carcinoma who have limited pulmonary oligometastasis and have received prior systemic therapy.

Not a fit: Patients with widespread metastases beyond the defined oligometastatic criteria or those with poor liver function may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with advanced liver cancer and limited lung metastases.

How similar studies have performed: While ablation has shown promise in treating various cancers, this specific approach for pulmonary oligometastasis in advanced HCC is relatively novel and requires further clinical validation.

Eligibility criteria

Inclusion Criteria:

1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
2. presence of pulmonary oligometastasis, the metastases found within three month of HCC diagnosis;
3. metastases with limited five sites and no more two organs involved, with a maximum diameter of ≤5cm;
4. 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);
5. undergone locoregional treatments, including transarterial artery chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) were included;
6. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
7. no history of other malignancies.
8. life expectancy more than 3 months;
9. agreed to participated in this clinical trial;
10. 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:

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

Where this trial is running

Beijing, Beijing Municipality

• Chinese PLA General hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Qunfang Zhou, MD

Conditions Advanced Hepatocellular Carcinoma; Lung Cancer; Oligometastasis; Ablation; Systemic Therapy; Advanced hepatocellular carcinoma; Lenvatinib; Sorafeinib