NCT06550921 Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma
| NCT ID | NCT06550921 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Advanced Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-08-01 with a primary completion date of 2026-08-01.
⚠ 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 approach for treating intrathoracic metastases. However, for hepatocellular carcinoma with oligometastasis, ablation of metastases remains relatively unexplored.
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 20; 2. presence of 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 Lenvatinib and PD-1 inhibitor as the first-line systemic therapy for a minimum of 3 months before study 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); 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. recurrent HCC; 2. advanced HCC Lenvatinib and PD-1 inhibitor treated with as second systemic therapy; 3. age \< 18 years or \> 75 years; 4. advanced HCC with more than five metastases; 5. no response to Lenvatinib; 6. metastases size \> 5 cm; 7. life expectancy less than 3 months.
Contact & Investigator
Feng Duan, MD
PRINCIPAL INVESTIGATOR
Chinese PLA General Hospital
Frequently Asked Questions
Who can join the NCT06550921 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 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 NCT06550921 currently recruiting?
Yes, NCT06550921 is actively recruiting participants. Contact the research team at zhouqun988509@163.com for enrollment information.
Where is the NCT06550921 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06550921 clinical trial?
NCT06550921 is sponsored by Sun Yat-sen University. The principal investigator is Feng Duan, MD at Chinese PLA General Hospital. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.