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Atezolizumab + Bevacizumab was superior to sorafenib in overall survival in advanced hepatocellular carcinoma. The programmed cell death protein-1 (PD1) and PDL1 inhibitor, was effective and tolerable in patients with advanced hepatocellular carcinoma. We aimed to describe the efficacy and safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in patients with advanced hepatocellular carcinoma who can not receive radical therapy.
This study is a multicenter, observational real-world study to explore the efficacy, safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in advanced hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with Bevacizumab and PD-1/L1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing locoregional therapy combined Bevacizumab and PD-1/L1 inhibitor as standard of care in hopes of answering key clinical questions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Locoregional therapy | Procedure | TACE procedure The decision to utilize transarterial artery chemoembolization (TACE) was performed through the tumor-feeding artery. The embolization emulsion was a mixture of Epirubicin 30-60 mg, Lobaplatin 30-50 mg, and Lipiodol 10-30 ml, and it was infused into tumor-feeding arteries via a 2.7/2.8 Fr micro-catheter. HAIC 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. |
| |
| Bevacizumab | Drug | 15mg/kg or 7.5mg/kg intravenously every 3 weeks | ||
| Atezolizumab | Drug | 1200mg intravenously every 3 weeks | ||
| Tislelizumab | Drug | 200mg intravenously every 3 weeks | ||
| Toripalimab |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free-Survival (PFS) | Progression was defined as progressive disease by independent radiologic review | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS is the length of time from the date of inclusion until death from any cause. | 24 months |
| Objective response rate (ORR) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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This study is a multicenter, observational real-world study to explore the efficacy, safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in advanced hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with Bevacizumab and PD-1/L1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing locoregional therapy combined Bevacizumab and PD-1/L1 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 | 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 hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| Drug |
220mg intravenously every 3 weeks |
| Sintilimab | Drug | 200mg intravenously every 3 weeks |
| Camrelizumab | Drug | 200mg intravenously every 3 weeks |
| 12 months |
| Adverse events | Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations | 24 months |
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C000594389 | atezolizumab |
| C000707970 | tislelizumab |
| C000656314 | toripalimab |
| C000632826 | sintilimab |
| C000631724 | camrelizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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