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| Name | Class |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | INDUSTRY |
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It is a trial to assess the efficacy and safety of Penpulimab and Anlotinib in Combination With Nab-paclitaxel Plus Gemcitabine as first-line Therapy in Patients (Pts) With Metastatic Pancreatic Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penpulimab | Drug | Penpulimab 200 mg administered intravenously every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective response rate is defined as the percentage of subjects whose best response was complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors Criteria(RECIST v1.1). | up to 3 years |
| Disease Control Rate (DCR) | Disease control rate is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST v1.1. | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival (OS) (median) is determined using the number of months measured from the initial date of treatment to the recorded date of death of participants. | up to 3 years |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38844468 | Derived | Sha H, Tong F, Ni J, Sun Y, Zhu Y, Qi L, Li X, Li W, Yang Y, Gu Q, Zhang X, Wang X, Zhu C, Chen D, Liu B, Du J. First-line penpulimab (an anti-PD1 antibody) and anlotinib (an angiogenesis inhibitor) with nab-paclitaxel/gemcitabine (PAAG) in metastatic pancreatic cancer: a prospective, multicentre, biomolecular exploratory, phase II trial. Signal Transduct Target Ther. 2024 Jun 7;9(1):143. doi: 10.1038/s41392-024-01857-6. |
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| Anlotinib | Drug | 12mg, continuous oral 2 weeks stop for 1 week, 21 days for a treatment cycle. |
|
| Nab paclitaxel | Drug | 125mg/m^2,administered intravenously on days 1 and 8 of every 21-day cycle. |
|
| Gemcitabine | Drug | 1.0g/m^2, administered intravenously on days 1 and 8 of every 21-day cycle. |
|
Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
| up to 3 years |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000720860 | penpulimab |
| C000625192 | anlotinib |
| D013660 | Taxes |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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