Advanced Pancreatic Cancer
Conditions
Keywords
PEG-rhG-CSF
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.
Interventions
DRUGPEG-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.
Sponsors
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
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
* (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 proportion of patients hospitalized due to neutropenia | It lasts 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. | It lasts 4 cycles(each cycle is 21 days) | The proportion of patients receiving antibiotics during the entire chemotherapy period. |
Countries
China
Contacts
Primary ContactGuanghai Dai
Outcome results
None listed