Clinical trial NCT04239001: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Pancreatic Cancer
Keywords: PEG-rhG-CSF
Lead sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
timeFrame: It lasts 4 cycles(each cycle is 21 days)
Secondary outcomes:
measure: The incidence of febrile neutropenia in each cycle of chemotherapy
timeFrame: It lasts 4 cycles(each cycle is 21 days)
measure: Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy
timeFrame: It lasts 4 cycles(each cycle is 21 days)
measure: The proportion of patients hospitalized due to neutropenia
timeFrame: It lasts 4 cycles(each cycle is 21 days)
measure: The proportion of patients receiving antibiotics during the entire chemotherapy period.
timeFrame: It lasts 4 cycles(each cycle is 21 days)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital First medical center
Study officials:
affiliation: Chinese PLA General Hospital First medical center
name: Guanghai Dai
role: PRINCIPAL_INVESTIGATOR
References: