Chinese PLA General hospital
Beijing, None Selected, 100853, China
Location status: Recruiting
Location contact
Feng Duan
CONTACT
Qunfang Zhou
CONTACT
NCT Number: NCT06609850
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Beijing, None Selected, 100853, China
Location status: Recruiting
Feng Duan
CONTACT
Qunfang Zhou
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(5) RHCC >5cm; (6) extrahepatic metastasis; (7) macrovascular tumor thrombus;
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.
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.
Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight <60 kg) orally once a day )
Time frame: 24 months
PFS is defined as the time from the date of inclusion to the date of the first objectively documented tumor progression or death due to any cause.
Time frame: 36 month
OS is the length of time from the date of inclusion until death from any cause.
Time frame: 12 months
ORR, as determined based on tumor response according to mRECIST, is defined as partial response and complete response.
Contact information is provided by the study sponsor or research team.
Feng Duan
CONTACT
Qunfang Zhou
CONTACT
Sun Yat-sen University
Other
The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma: a Multicenter Randomized Control Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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