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Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC.
This study is a multicenter, observational real-world study to explore the efficacy, safety of lenvatinib and PD-1 inhibitor with HAIC in advanced infiltrative hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with lenvatinib and PD-1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC combined lenvatinib and PD-1 inhibitor as standard of care in hopes of answering key clinical questions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAIC+Len+PD-1 inhibitor group | HAIC combined with Lenatinib and PD-1 inhibitor group |
| |
| Len group | Lenvatinib alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatic arterial infusion chemotherapy | Procedure | Hepatic arterial infusion chemotherapy (HAIC) procedure was performed with FOLFOX regimen: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | OS is the length of time from the date of inclusion until death from any cause. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free-Survival | Progression was defined as progressive disease by independent radiologic review | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response. | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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This study is a multicenter, observational real-world study to explore the efficacy, safety of lenvatinib and PD-1 inhibitor with HAIC in advanced infiltrative hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with lenvatinib and PD-1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC combined lenvatinib and PD-1 inhibitor as standard of care in hopes of answering key clinical questions.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qunfang Zhou, MD | Contact | 86 19868000115 | zhouqun988509@163.com | |
| Feng Duan, MD | Contact | 86 13910984586 | duanfeng@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Duan, MD | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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|
| Lenvatinib | Drug | 12 mg (body weight ≥60 kg) , 8 mg (body weight <60 kg) orally once a day |
|
| Tislelizumab | Drug | 200mg intravenously every 3 weeks |
|
| Toripalimab | Drug | 240mg intravenously every 3 weeks |
|
| Sintilimab | Drug | 200mg intravenously every 3 weeks |
|
| Camrelizumab | Drug | 200mg intravenously every 3 weeks |
|
| 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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| ID | Term |
|---|---|
| C531958 | lenvatinib |
| C000707970 | tislelizumab |
| C000656314 | toripalimab |
| C000632826 | sintilimab |
| C000631724 | camrelizumab |
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