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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

Primary Purpose

Advanced Pancreatic Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PEG-rhG-CSF
Sponsored by
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Advanced Pancreatic Cancer focused on measuring PEG-rhG-CSF

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese PLA General Hospital First medical centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEG-rhG-CSF

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
Incidence of degree 3-4 neutropenia in each cycle of chemotherapy

Secondary Outcome Measures

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
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
The proportion of patients hospitalized due to neutropenia
The proportion of patients hospitalized due to neutropenia
The proportion of patients receiving antibiotics during the entire chemotherapy period.
The proportion of patients receiving antibiotics during the entire chemotherapy period.

Full Information

First Posted
January 9, 2020
Last Updated
January 20, 2020
Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04239001
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Pancreatic Cancer
Keywords
PEG-rhG-CSF

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEG-rhG-CSF
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
PEG-rhG-CSF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
Description
Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
Time Frame
It lasts 4 cycles(each cycle is 21 days)
Secondary Outcome Measure Information:
Title
The incidence of febrile neutropenia in each cycle of chemotherapy
Description
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
Time Frame
It lasts 4 cycles(each cycle is 21 days)
Title
Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy
Description
Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy
Time Frame
It lasts 4 cycles(each cycle is 21 days)
Title
The proportion of patients hospitalized due to neutropenia
Description
The proportion of patients hospitalized due to neutropenia
Time Frame
It lasts 4 cycles(each cycle is 21 days)
Title
The proportion of patients receiving antibiotics during the entire chemotherapy period.
Description
The proportion of patients receiving antibiotics during the entire chemotherapy period.
Time Frame
It lasts 4 cycles(each cycle is 21 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guanghai Dai
Phone
13801232381
Email
daigh60@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guanghai Dai
Organizational Affiliation
Chinese PLA General Hospital First medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital First medical center
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guanghai Dai
Phone
13801232381
Email
daigh60@sohu.com

12. IPD Sharing Statement

Learn more about this trial

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

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