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This study intends to evaluate the efficacy and safety of blank- microsphere transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (bTAE-HAIC) plus Lenvatinib and Camrelizumab for patients with infiltrative hepatocellular carcinoma.
Blank-microsphere transcatheter arterial embolization (bTAE) and hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin are effective and safe for hepatocellular carcinoma. Lenvatinib is non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. Sintilimab, a programmed cell death protein-1 (PD-1) inhibitor, is effective and safe in patients with unresectable hepatocellular carcinoma. No study has evaluated bTAE-HAIC plus Lenvatinib and Sintilimab. Thus, the investigators carried out this prospective, single-arm study to find out it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bTAE-HAIC combined with Lenvatinib and Sintilimab | Experimental | bTAE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then blank microspheres were used according to the tumor blood supply vessels (40-120um, 100-300um, 300-500um, 500-700um). Hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin every 4 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Sintilimab, 200 mg intravenously every 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bTAE-HAIC | Procedure | bTAE procedure was a 2.8-F microcatheter was superselectively inserted into the tumor feeding artery using the coaxial technique. Then blank microspheres were used according to the tumor blood supply vessels (40-120um, 100-300um, 300-500um, 500-700um). The microcatheter was reserved at the proper/left/right hepatic artery according tumor location. After the patient returned to the ward, the following FOLFOX-based regime was intra-arterially administered through the microcatheter. The FOLFOX regimen was administered via the hepatic artery as follows: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1, and 400 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 |
|---|---|---|
| Objective response rate (ORR) | ORR, as determined based on tumor response according to RECIST 1.1 | 6 months |
| 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. | 6 months |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qunfnag Zhou, MD | Contact | 86 19868000115 | zhouqun988509@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhimei Hunag, MD | Sun Yat-sen University | Study Director |
| Jinhua Huang, Professor | Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
| C000632826 | sintilimab |
| D000906 | Antibodies |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
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| Lenvatinib | Drug | 12 mg (or 8 mg) once daily (QD) oral dosing. |
|
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| Sintilimab | Drug | 200mg intravenously every 32 weeks |
|
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OS is the length of time from the date of inclusion until death from any cause.
| 12 months |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |