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This is a multicenter, single-arm, open-label phase II study to evaluate the efficacy and safety of PM8002 in combination with chemotherapy in the first-line treatment of subjects with inoperable HCC.
PM8002 is a Bispecific Antibody Targeting PD-L1 and VEGF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PM8002+FOLFOX-4 | Experimental | PM8002 20mg/kg Q2W day 1: oxaliplatin [85 mg/m2, 2-h infusion] plus leucovorin [200 mg/m2, 2-h infusion], followed by 5-fluorouracil [400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion]; day 2: leucovorin [200 mg/m2, 2-h infusion], followed by 5-fluorouracil [400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PM8002 | Biological | PM8002 20mg/kg Q2W |
| |
| FOLFOX regimen |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1. | Up to approximately 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jieer Ying | Cancer Hospital of The University of Chinese Academy of Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | China | |||
| Fujian Cancer Hospital |
The data will be published or presented for publications (poster, abstract, articles or papers) or any presentations.
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C410216 | Folfox protocol |
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| Drug |
day 1: oxaliplatin [85 mg/m2, 2-h infusion] plus leucovorin [200 mg/m2, 2-h infusion], followed by 5-fluorouracil [400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion]; day 2: leucovorin [200 mg/m2, 2-h infusion], followed by 5-fluorouracil [400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion] |
|
| Fuzhou |
| Fujian |
| China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China |
| Henan Cancer Hospital | Zhengzhou | Henan | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | China |
| The First Hospital of Jilin University | Changchun | Jilin | China |
| Cancer Hospital of The University of Chinese Academy of Sciences | Hangzhou | Zhejiang | China |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Jinhua Municipal Centeral Hospital Medical Group | Jinhua | Zhejiang | China |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |