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A prospective, open, one-arm clinical study to evaluate the efficacy and safety of jinyouli in the first-line treatment of advanced pancreatic cancer with albumin paclitaxel combined with S-1.Chemotherapy regimen: (1) chemotherapy: albumin paclitaxel, 120mg / m2, intravenous infusion for 30 minutes, D1. S-1, taken orally after meal, D1 - 14. (2) patients who met the input / discharge criteria were given jinyouli injections 24 hours after the end of intravenous infusion of albumin paclitaxel during the treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-rhG-CSF | Experimental | Jin Youli(PEG-rhG-CSF): jinyouli injection was given 24 hours after the completion of intravenous infusion of albumin paclitaxel during the treatment period, 6 mg was given to patients with body weight ≥45 kg, and 3 mg was given for body weight <45 kg. Inject once every chemotherapy cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-rhG-CSF | Drug | 24 hours after the completion of intravenous infusion of albumin paclitaxel during the treatment period, patients with pancreatic cancer who met the input / discharge criteria were given secondary prophylactic administration of the tested drug PEG-rhG-CSF. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of degree 3-4 neutropenia in each cycle of chemotherapy | Incidence of degree 3-4 neutropenia in each cycle of chemotherapy | It lasts 4 cycles(each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of febrile neutropenia in each cycle of chemotherapy | Febrile neutropenia (FN) is defined as oral temperature >38.3 ° C (underarm temperature >38.1 ° C) or continuous measurement of oral temperature >38 ° C (underarm temperature >37.8 ° C) in 2 h, and ANC <0.5×10^9/L, or expected to be <0.5×10^9/L | It lasts 4 cycles(each cycle is 21 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guanghai Dai | Contact | 13801232381 | daigh60@sohu.com |
| Name | Affiliation | Role |
|---|---|---|
| Guanghai Dai | Chinese PLA General Hospital First medical center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital First medical center | Recruiting | Beijing | China |
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| Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy | Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy | It lasts 4 cycles(each cycle is 21 days) |
| The proportion of patients hospitalized due to neutropenia | The proportion of patients hospitalized due to neutropenia | It lasts 4 cycles(each cycle is 21 days) |
| The proportion of patients receiving antibiotics during the entire chemotherapy period. | The proportion of patients receiving antibiotics during the entire chemotherapy period. | It lasts 4 cycles(each cycle is 21 days) |
| ID | Term |
|---|---|
| C423652 | pegylated granulocyte colony-stimulating factor |
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