PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Open, Single-arm Clinical Study Evaluating the Efficacy and Safety of PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in the First-line Treatment of Advanced Pancreatic Cancer

Conditions
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PEG-rhG-CSF, Pancreatic Cancer

Intervention / Treatment
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* Drug: Jin Youli(PEG-rhG-CSF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years, ≤70 years; Patients with Advanced Pancreatic Cancer diagnosed by histopathology，the expected survival time is more than 3 months; Neutropenia of ≥2 degree occurred with the nab-paclitaxel + S-1 regimen in the previous cycle. KPS score≥70; The peripheral blood routine of the patients was normal: ANC ≥ 2.0x10^9/L, platelet count ≥ 90x10^9/L, HB ≥ 80g/L before enrollment, and there was no bleeding tendency; Patients volunteered to participate in the trial, signed a written informed consent, willing to be followed up. Exclusion Criteria: There are uncontrollable infections at the moment or systemic antibiotic treatment within 72 h of chemotherapy； Any abnormal bone marrow hyperplasia and other abnormal hematopoietic function； Patients who had received bone marrow or hematopoietic stem cell transplantation within 3 months； Patients with other malignancies that have not been cured or with brain metastases； Total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5 ULN, or >5 ULN if there is liver metastasis; Serum creatinine (Cr) exceeded the upper limit of normal value； Allergic to this product or other biological products derived from genetically engineered escherichia coli； Suffering from a mental or nervous system disorder, without self-awareness or coordination； Patients expected to have a short survival or have difficulty tolerating chemotherapy； Pregnant or lactating female patients； Patients using other drugs of the same category or in clinical trials of other drugs； Not suitable for participation at investigators' discretion.

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: Jin Youli(PEG-rhG-CSF)<br>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). | Drug: Jin Youli(PEG-rhG-CSF)<br>* 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<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 | last 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℃ 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEG-rhG-CSF, Secondary Prevention, Pancreatic Cancer