NCT06644430 Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma
| NCT ID | NCT06644430 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Advanced Hepatocellular Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 470 participants |
| Start Date | 2024-10-04 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 470 participants in total. It began in 2024-10-04 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Feng Duan, MD
STUDY DIRECTOR
Chinese PLA General Hospital
Frequently Asked Questions
Who can join the NCT06644430 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Advanced Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06644430 currently recruiting?
Yes, NCT06644430 is actively recruiting participants. Contact the research team at zhouqun988509@163.com for enrollment information.
Where is the NCT06644430 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06644430 clinical trial?
NCT06644430 is sponsored by Sun Yat-sen University. The principal investigator is Feng Duan, MD at Chinese PLA General Hospital. The trial plans to enroll 470 participants.
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