Efficacy and Safety of Pegylated Recombinant Human Granulocyte Stimulating Factor in Secondary Prevention of Albumin Paclitaxel Combined With S-1 in the First-line Treatment of Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Open, One-arm Clinical Study Evaluating the Efficacy and Safety of Pegylated Recombinant Human Granulocyte Stimulating Factor in Secondary Prevention of Albumin Paclitaxel Combined With S-1 in the First-line Treatment of Advanced Pancreatic Cancer

Conditions
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Advanced Pancreatic Cancer

Intervention / Treatment
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* Drug: PEG-rhG-CSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) Age ≥ 18 years, ≤70 years; (2) Patients with Advanced Pancreatic Cancer diagnosed by histopathology，the expected survival time is more than 3 months; (3) Neutropenia of ≥2 degree occurred with the albumin paclitaxel + S-1 regimen in the previous cycle. (4) KPS score≥70points; (5) The peripheral blood routine of the patients was normal: ANC ≥ 2.0x109 / L, platelet count ≥ 90 × 109 / L, HB ≥ 80g / L before enrollment, and there was no bleeding tendency; (6) Patients volunteered to participate in the trial and signed a written informed consent to be followed up. Exclusion Criteria: (1) There are currently hard-to-control infections or systemic antibiotic treatment within 72 h of chemotherapy； (2) Any abnormal bone marrow hyperplasia and other abnormal hematopoietic function； (3) Patients who had received bone marrow or hematopoietic stem cell transplantation within the previous 3 months； (4) Previous patients with other malignant tumors not cured, or brain metastases； (5) Liver function tests total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are >2.5 times the upper limit of normal, if the above indicators are >5 times due to liver metastasis Upper limit of normal value; (6) Renal function test: serum creatinine (Cr) exceeded the upper limit of normal value； (7) Allergic to this product or other biological products derived from genetically engineered escherichia coli； (8) Suffering from a mental or nervous system disorder, lacking self-awareness or coordination； (9) Patients who are expected to have a short survival and have difficulty tolerating chemotherapy； (10) Pregnant and nursing female patients； (11) People who are using other drugs of the same category or are in clinical trials of other drugs； (12) The investigator judges patients who are not suitable for participation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-rhG-CSF<br>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 | Drug: PEG-rhG-CSF<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEG-rhG-CSF