Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma

Sun Yat-sen University

Status: Enrolling

Conditions: Ablation; Lung Cancer; Systemic Therapy; Oligometastasis; Advanced Hepatocellular Carcinoma

Treatments: Drug: system therapy; Procedure: Ablation

Study type: Observational

Funder types: Other

Identifiers

NCT06644430

CHEST-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 470 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

470 participants in 2 patient groups

Ablation+system group

Description:

Participants received ablation of plumonary combined systemic therapy

Treatment:

Procedure: Ablation

Drug: system therapy

System group

Description:

Participants received systemic therapy

Treatment:

Drug: system therapy