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A prospective, open, single-arm clinical study to evaluate the efficacy and safety of jinyouli(PEG-rhG-CSF) in the first-line treatment of advanced pancreatic cancer with nab-paclitaxel combined with S-1.Chemotherapy regimen: (1) chemotherapy: nab-paclitaxel, 260mg/m2, intravenous infusion for 30 minutes, D1, Q3W. S-1, 80-120mg, PO BID, D1-14, Q3W. (2) patients who met the eligibility criteria were given jinyouli injections 24 hours after the end of intravenous infusion of nab-paclitaxel during the treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jin Youli(PEG-rhG-CSF) | Experimental | PEG-rhG-CSF Secondary Prevention:patients with pancreatic cancer who met the eligibility criteria were given secondary prophylactic administration of the Jin Youli(PEG-rhG-CSF). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jin Youli(PEG-rhG-CSF) | Drug | Jin Youli(PEG-rhG-CSF) 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 |
| 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 | last 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℃ or continuous measurement of oral temperature >38.1℃ in 1h, with ANC <0.5×10^9/L or expected to be <0.5×10^9/L | last 4 cycles(each cycle is 21 days) |
| Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guanghai Dai, PhD. | Contact | 13801232381 | daigh60@sohu.com |
| Name | Affiliation | Role |
|---|---|---|
| Guanghai Dai, PhD. | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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|
Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy |
| last 4 cycles(each cycle is 21 days) |
| The proportion of patients hospitalized due to neutropenia | The proportion of patients hospitalized due to neutropenia | last 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. | last 4 cycles(each cycle is 21 days) |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |