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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE plus Lenvatinib | Active Comparator | 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 ) |
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| TACE plus Lenvatinib and ablation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS is the length of time from the date of inclusion until death from any cause. | 36 month |
| Objective response rate (ORR) | ORR, as determined based on tumor response according to mRECIST, is defined as partial response and complete response. |
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Inclusion Criteria:
Exclusion Criteria:
(5) RHCC >5cm; (6) extrahepatic metastasis; (7) macrovascular tumor thrombus;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qunfang Zhou | Contact | 86 19868000115 | zhouqun988509@163.com | |
| Feng Duan | Contact | 86 13910984586 | duanfeng@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Duan | Chinese PLA General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General hospital | Recruiting | Beijing | None Selected | 100853 | China |
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| Ablation | 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. |
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| Lenvatinb | Drug | Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight <60 kg) orally once a day ) |
|
| 12 months |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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