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

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Advanced Pancreatic Cancer

Interventions

PEG-rhG-CSF

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.