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Trial Title:
Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma
NCT ID:
NCT06550921
Condition:
Advanced Hepatocellular Carcinoma
Oligometastasis
Ablation
Anti-PD1 Antibody
Lenvatinib
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Lenvatinb
Tislelizumab
Sintilimab
Camrelizumab
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
ablation of oligometastasis
Description:
The oligometastasis of hepatocellular carcinoma are ablation completely by ablation
(including microwave ablation, radiofrequency ablation, and cryoablation)
Arm group label:
Ablation-Len-PD-1 inhibitor
Summary:
Ablation has been an effective approach for treating intrathoracic metastases. However,
for hepatocellular carcinoma with oligometastasis, ablation of metastases remains
relatively unexplored.
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. Thus, we conduct this multicenter single arm study to explore the efficacy,
safety of lenvatinib and PD-1 inhibitor with metastases-directed ablation in advanced
HCC. This study focuses on the management of ablation of oligometastasis therapy combined
with lenvatinib and PD-1 inhibitor. This study aims to evaluate the survival benefits of
ablating oligometastasis for advanced HCC.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese PLA General hospital
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Qunfang Zhou
Email:
zhouqun988509@163.com
Contact backup:
Last name:
Feng Duan
Phone:
8613910984586
Email:
duanfeng@vip.sina.com
Start date:
August 1, 2024
Completion date:
August 30, 2027
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06550921
