PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in Advanced Pancreatic Cancer
- Conditions
- PEG-rhG-CSFPancreatic Cancer
- Interventions
- Drug: Jin Youli(PEG-rhG-CSF)
- Registration Number
- NCT04518800
- Lead Sponsor
- Chinese PLA General Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Jin Youli(PEG-rhG-CSF) Jin Youli(PEG-rhG-CSF) 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).
- Primary Outcome Measures
Name Time Method Incidence of degree 3-4 neutropenia in each cycle of chemotherapy last 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. last 4 cycles(each cycle is 21 days) The proportion of patients receiving antibiotics during the entire chemotherapy period.
The incidence of febrile neutropenia in each cycle of chemotherapy last 4 cycles(each cycle is 21 days) 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
Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy last 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 last 4 cycles(each cycle is 21 days) The proportion of patients hospitalized due to neutropenia
Trial Locations
- Locations (1)
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China