Pancreatic Cancer, PEG-rhG-CSF
Conditions
Keywords
PEG-rhG-CSF, Secondary Prevention, Pancreatic Cancer
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.
Interventions
DRUGJin Youli(PEG-rhG-CSF)
Jin Youli(PEG-rhG-CSF) 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
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
China
Contacts
Primary ContactGuanghai Dai, PhD.
Outcome results
None listed