Ablation, Advanced Hepatocellular Carcinoma, Lung Cancer, Oligometastasis, Systemic Therapy
Conditions
Keywords
Advanced hepatocellular carcinoma, Lenvatinib, Sorafeinib, Camrelizumab, Tislelizumab, Sintilimab, Toripalimab, Apatinib
Brief 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.
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
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.
Sponsors
Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free-Survival | 12 months | Progression was defined as progressive disease by independent radiologic review |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 24 months | OS is the length of time from the date of inclusion until death from any cause. |
| Objective response rate (ORR) | 12 months | ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response is either a complete response or partial response. |
Countries
China
Contacts
Primary ContactQunfang Zhou, MD
Backup ContactFeng Duan, MD
Outcome results
None listed