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
NCT ID: NCT04239001
Last Updated: 2020-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2020-02-29
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* (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
* (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.
18 Years
70 Years
ALL
No
Sponsors
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CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Guanghai Dai
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital First medical center
Locations
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Chinese PLA General Hospital First medical center
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CSPC -JYL-PC-01
Identifier Type: -
Identifier Source: org_study_id
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