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Trial Title:
The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma
NCT ID:
NCT06609850
Condition:
Recurrent Hepatocellular Carcinoma
Lenvatinib
Local Therapy
Ablation
Systemic Therapy
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Conditions: Keywords:
Lenvatinb
Hepatocellular carcinoma
Microwave ablation
Radiofrequency ablation
Cryoablation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
TACE
Description:
TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor
feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml),
lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined
technical success as complete embolization of the tumor-feeding artery resulting in no
tumor staining observed by angiogram at the end of procedure.
Arm group label:
TACE plus Lenvatinib
Arm group label:
TACE plus Lenvatinib and ablation
Intervention type:
Procedure
Intervention name:
Ablation
Description:
Ablation (radiofrequency ablation, microwave ablation, cryoablation), ablation followed
TACE within 6-8 weeks and Lenvatinib continued. Percutaneous ablation was performed by
ultrasound or CT. The ablation success is evaluated by achieving an ablative margin of
0.5 cm or more than the tumor size.
Arm group label:
TACE plus Lenvatinib and ablation
Intervention type:
Drug
Intervention name:
Lenvatinb
Description:
Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight <60 kg) orally once a day )
Arm group label:
TACE plus Lenvatinib
Arm group label:
TACE plus Lenvatinib and ablation
Summary:
Studies have shown that combination therapy of TACE with Lenvatinib could achieve better
survival outcomes than TACE alone for hepatocellular carcinoma (HCC) at BCLC B stage.
However, whether patients could benefit from the ablation for intermediate recurrent HCC
(RHCC) is still need high quality clinical evidence. This study is to evaluate the
efficacy of ablation combined with TACE and Lenvatinib for the intermediate-stage RHCC.
Detailed description:
The evidence of ablation combined transarterial chemoembolisation (TACE) and Lenvatinib
for intermediate-stage recurrent hepatocellular carcinoma (RHCC) is limited. Patient
responses to this treatment vary because of the heterogeneous nature of RHCC. Thus, it is
important to identify patients who are most likely to benefit from this three regimes
therapy. The aim of this study is to comparison of TACE-Lenvatinib with
TACE-Lenvatinib-ablation for intermediate RHCC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 18-75 years;
2. RHCC diagnosed by imaging;
3. intermediate-stage RHCC (two to three lesions which at least one was >3 cm in size
or more than three tumors);
4. the tumor number was no more than six, and the maximum tumor diameter was ≤5 cm;
5. absence of extrahepatic metastasis or macrovascular invasion;
6. Child-Pugh class A or B;
7. TACE as initial treatment after tumor recurrence and showed no tumor progression
after TACE.
8. life expectance >3 months;
Exclusion Criteria:
1. under 18 years or over 75 years of age;
2. primary intermediate-stage HCC;
3. RHCC with more than six tumors, or single RHCC
(5) RHCC >5cm; (6) extrahepatic metastasis; (7) macrovascular tumor thrombus;
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
Phone:
8619868000115
Email:
zhouqun988509@163.com
Contact backup:
Last name:
Feng Duan
Phone:
8613910984586
Email:
duanfeng@vip.sina.com
Start date:
October 1, 2024
Completion date:
October 30, 2028
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/NCT06609850
