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Due to the company's development strategy adjustment ,Innovent Bioligics decided not to continue the study after consultation with investigators.
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The purpose of this phase Ib study is to assess the safety, tolerability and effectiveness of IBI318 in combination with conventional TACE (cTACE) in patients with potentially resected hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI318 combined with conventional TACE (cTACE) | Experimental |
| |
| Placebo combined with conventional TACE (cTACE) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI318 | Drug | before surgery IBI318 intravenous injection Q2W,after surgery IBI318 intravenous injection Q4W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing clinical and laboratory adverse events (AEs) | Up to 90 days post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of subjects with pathological Complete Response (pCR) after liver resection | 3 years | |
| The percentage of subjects with major pathological response (MPR) after liver resection | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital Zhejiang University | Hangzhou | Zhejiang | China |
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| cTACE | Procedure | conventional transarterial chemoembolization |
|
| placebo | Drug | before surgery placebo intravenous injection Q2W,after surgery placebo intravenous injection Q4W |
|
| The percentage of subjects with R0 resection | 3 years |
| Objective response rate (ORR) in two arms based on mRECIST by investigator | 3 years |
| Disease-free survival (DFS) in two arms based on mRECIST by investigator | 3 years |
| Overall survival (OS) in two arms | 3 years |
| 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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