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

Not Applicable

• Conditions: Advanced Pancreatic Cancer
• Interventions: Drug: PEG-rhG-CSF

• Registration Number: NCT04239001
• Lead Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-20
• Last Update Submitted: 2020-01-20
• Study First Posted: 2020-01-23
• Last Update Posted: 2020-01-23
• Study Start: 2020-02
• Primary Completion: 2020-12
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEG-rhG-CSF	PEG-rhG-CSF	Jin Youli(PEG-rhG-CSF): jinyouli injection 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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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.

Trial Locations

Locations (1)

Chinese PLA General Hospital First medical center; 🇨🇳 Beijing, China