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 Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PEG-rhG-CSF 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
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.
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Outcome Measures
Primary Outcome Measures
- Incidence of degree 3-4 neutropenia in each cycle of chemotherapy [It lasts 4 cycles(each cycle is 21 days)]
Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
Secondary Outcome Measures
- The incidence of febrile neutropenia in each cycle of chemotherapy [It lasts 4 cycles(each cycle is 21 days)]
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
- Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy [It lasts 4 cycles(each cycle is 21 days)]
Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy
- The proportion of patients hospitalized due to neutropenia [It lasts 4 cycles(each cycle is 21 days)]
The proportion of patients hospitalized due to neutropenia
- The proportion of patients receiving antibiotics during the entire chemotherapy period. [It lasts 4 cycles(each cycle is 21 days)]
The proportion of patients receiving antibiotics during the entire chemotherapy period.
Eligibility Criteria
Criteria
Inclusion Criteria:
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(1) Age ≥ 18 years, ≤70 years;
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(2) Patients with Advanced Pancreatic Cancer diagnosed by histopathology，the expected survival time is more than 3 months;
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(3) Neutropenia of ≥2 degree occurred with the albumin paclitaxel + S-1 regimen in the previous cycle.
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(4) KPS score≥70points;
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(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;
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(6) Patients volunteered to participate in the trial and signed a written informed consent to be followed up.
Exclusion Criteria:
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(1) There are currently hard-to-control infections or systemic antibiotic treatment within 72 h of chemotherapy；
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(2) Any abnormal bone marrow hyperplasia and other abnormal hematopoietic function；
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(3) Patients who had received bone marrow or hematopoietic stem cell transplantation within the previous 3 months；
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(4) Previous patients with other malignant tumors not cured, or brain metastases；
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(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;
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(6) Renal function test: serum creatinine (Cr) exceeded the upper limit of normal value；
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(7) Allergic to this product or other biological products derived from genetically engineered escherichia coli；
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(8) Suffering from a mental or nervous system disorder, lacking self-awareness or coordination；
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(9) Patients who are expected to have a short survival and have difficulty tolerating chemotherapy；
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(10) Pregnant and nursing female patients；
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(11) People who are using other drugs of the same category or are in clinical trials of other drugs；
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(12) The investigator judges patients who are not suitable for participation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chinese PLA General Hospital First medical center | Beijing | China |
Sponsors and Collaborators
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Guanghai Dai, Chinese PLA General Hospital First medical center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSPC -JYL-PC-01