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

Prospective, Open, One-arm Clinical Study Evaluating the 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

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 Overview

• Status: Unknown
• Conditions: Advanced Pancreatic Cancer
• Intervention / Treatment: Drug: PEG-rhG-CSF

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Chinese PLA General Hospital First Medical Center
    • Contact: Guanghai Dai; Phone Number: 13801232381; Email: daigh60@sohu.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: PEG-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of degree 3-4 neutropenia in each cycle of chemotherapy	Incidence of degree 3-4 neutropenia in each cycle of chemotherapy	It lasts 4 cycles(each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of febrile neutropenia in each cycle of chemotherapy	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	It lasts 4 cycles(each cycle is 21 days)
Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy	Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy	It lasts 4 cycles(each cycle is 21 days)
The proportion of patients hospitalized due to neutropenia	The proportion of patients hospitalized due to neutropenia	It lasts 4 cycles(each cycle is 21 days)
The proportion of patients receiving antibiotics during the entire chemotherapy period.	The proportion of patients receiving antibiotics during the entire chemotherapy period.	It lasts 4 cycles(each cycle is 21 days)

Collaborators and Investigators

• Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Guanghai Dai, Chinese PLA General Hospital First Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: PEG-rhG-CSF
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: CSPC -JYL-PC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No