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This is a single-arm, open-label, exploratory study to evaluate efficacy and safety of envafolimab combined with endostar and nab-paclitaxel plus gemcitabine for first-line treatment of advanced pancreatic cancer.
This study is a prospective, open-label, single-arm, exploratory clinical study.
Recruited 20 subjects who met the inclusion criteria and received Endostar+Envofolimab+Nab-paclitaxel/Gemcitabine (AG regimen) chemotherapy according to the study plan. Treatment duration and dose can be adjusted according to patient tolerance until disease progression or intolerable toxicity, or other conditions determined by the investigator. During the trial, the efficacy indicators and safety indicators were observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Envafolimab and Endostar plus AG regimen | Experimental | Envafolimab:400mg,sc,d1,Q4W; Endostar:210mg,CIV72h,d1-3,Q4W; Chemotherapy:AG (nab-paclitaxel:125mg/m2,iv,d1,d8,Q4W;gemcitabine:1000mg/m2, iv,d1,d8,Q4W). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Envafolimab | Drug | 400mg,sc,d1,Q4W |
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| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate | 6 months |
| PFS | Progressives free survival | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival | 12 months |
| DCR | disease controll rate | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengxiang Han, MD | Contact | 18052268612 | cnhzxyq@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221006 | China |
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| ID | Term |
|---|---|
| C000718749 | envafolimab |
| D007167 | Immunotherapy |
| C522911 | endostar protein |
| D043169 | Endostatins |
| D013660 | Taxes |
| D004358 | Drug Therapy |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D043165 | Angiostatic Proteins |
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| Endostar | Drug | 210mg,CIV72h,d1-3,Q4W |
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| Nab paclitaxel | Drug | 125mg/m2,iv,d1,d8,Q4W |
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| Gemcitabine | Drug | 1000mg/m2, iv,d1,d8,Q4W |
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| AEs |
Percentage of participants experiencing grade 3-5 adverse events |
| 12 months |
| D042501 |
| Angiogenic Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D043170 | Collagen Type XVIII |
| D024041 | Non-Fibrillar Collagens |
| D003094 | Collagen |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D001685 | Biological Factors |
| 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 |