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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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To evaluate the efficacy and safety of TACE combined with adebrelimab and bevacizumab transformation in unresectable hepatocellular carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE with adebrelimab and bevacizumab | Drug | TACE treatment once; Adebrelimab: 20mg/kg, every 3 weeks (21 days); Bevacizumab; 15mg/kg, every 3 weeks (21 days); |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | Refers to the proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to mRECIST 1.1 criteria. | Up to 2 years |
| Occurence of AE and SAE | Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0) | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Radical (R0) resection rate after conversion therapy | The cut margin had no residual cancer cells | Up to 2 years |
| percent conversion | The ates of conversion to operable patients in inoperable patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianbo Chen | Contact | 15605921022 | 274439002@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianbo Chen | The First Affiliated Hospital of Xiamen University | Principal Investigator |
| Feng Ye | The First Affiliated Hospital of Xiamen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | China |
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| Up to 2 years |
| Pathological complete response rate (pCR) | The rate of no remaining tumor cells in the excised tissue samples | Up to 2 years |
| Major pathological response rate (MPR) | The ratio of the tumor cells active in the removed tissue samples is less than 10%. | Up to 2 years |
| Progression-free survival (PFS) | PFS was defined as the subject's date from the date of the first dose to the date of the first documented tumor progression (as assessed by mRECIST criteria, with or without continuation of treatment) or the date of death from any cause, whichever occurred first. | Up to 2 years |
| Disease control rate(DCR) | Refers to the proportion of all subjects with the best overall response (BOR) according to mRECIST criteria as complete remission (CR), partial remission (PR) and stable disease (SD). | Up to 2 years |
| Relapse-free survival time (RFS) | Time from date of cure surgery to time of recurrence or death | Up to 2 years |
| Overall survival(OS) | Defined as the time from the date of the first dose to the death of the subject from any cause. | Up to 2 years |
| congren Wang |
| Quanzhou First Hospital |
| Study Director |
| Qinghe Cai | Affiliated Hospital of Putian University | Study Director |
| Jiafei Chen | Putian First Hospital | Study Director |
| Yongzhong Wang | Sanming Second Hospital | Study Director |
| Feng Lin | Ningde Mindong Hospital | Study Director |
| 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 |
|---|---|
| D000068258 | Bevacizumab |
| 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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