PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in Advanced Pancreatic Cancer

Chinese PLA General Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

PEG-rhG-CSF Pancreatic Cancer

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.