The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma
NCT ID: NCT06609850
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
116 participants
INTERVENTIONAL
2024-10-01
2028-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TACE plus Lenvatinib
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.
Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day )
TACE
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.
Lenvatinb
Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day )
TACE plus Lenvatinib and ablation
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.
Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day ) 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.
TACE
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
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
Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day )
Interventions
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TACE
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
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
Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day )
Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
75 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Zhou Qunfang
Clinical Professor
Principal Investigators
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Feng Duan
Role: STUDY_DIRECTOR
Chinese PLA General Hospital
Locations
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Chinese PLA General hospital
Beijing, None Selected, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Liver Projiect 10
Identifier Type: -
Identifier Source: org_study_id