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
- Registration Number
- NCT04239001
- Lead Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- (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.
- (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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PEG-rhG-CSF 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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 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
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
Trial Locations
- Locations (1)
Chinese PLA General Hospital First medical center
🇨🇳Beijing, China