Back to resultsPEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy
Primary Purpose
Small Cell Lung Cancer, PEG-rhG-CSF
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PEG-rhG-CSF
Sponsored by
About this trial
This is an interventional prevention trial for Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 70 years old, gender is not limited;
- Small cell lung cancer patients diagnosed by histopathology or cytology;
- ECOG = 0-1;
- The estimated survival period is more than 3 months;
- No obvious signs of hematological disease, defined as Hb≥90g/dL, WBC≥4.0×10^9/L, ANC≥2×10^9/L, PLT≥100×10^9/L before enrollment. And no bleeding tendency;
- No obvious abnormalities were observed in the electrocardiogram examination;
- Liver function tests ALT, AST, TBIL indicators are within 2.5 times the upper limit of normal values. If due to liver metastasis, the above indicators should be within 5 times of the upper limit of normal. If LDH is elevated due to non-tumor causes, LDH should be ≤ 2.5 times the upper limit of normal; if LDH is elevated due to tumor, it can be enrolled;
- Renal function test BUN, UA within 1.5 times the upper limit of normal value, creatinine clearance rate> 60ml / min;
- Subjects (or their legal representatives/guardians) must sign an informed consent form indicating that they understand the purpose of the study, understand the necessary procedures for the study, and are willing to participate in the study.
Exclusion Criteria:
- There are currently uncontrollable infections, body temperature ≥ 38.0 ° C;
- Patients with previous malignant tumors that have not been cured or have bone marrow metastasis;
- Patients with prophylactic antibiotics;
- Accepting other test drugs at the same time or participating in other clinical trials;
- Those who are allergic to this product or other genetically engineered E. coli-derived biological products;
- The patient has any myelodysplastic and other blood system diseases;
- Patients who have received hematopoietic stem cell transplantation or organ transplantation;
- The patient has a severe mental or neurological condition that affects informed consent and/or adverse reaction presentation or observation.
Sites / Locations
- Bejing Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PEG-rhG-CSF
Arm Description
Jin Youli(PEG-rhG-CSF): The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were <45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle. Dosing time: 48 h after chemotherapy.
Outcomes
Primary Outcome Measures
The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.
The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.
Secondary Outcome Measures
The incidence of febrile neutropenia in cycles 1 and 2
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 ANC recovery time in cycles 1 and 2
Defined as the patients who appear ANC<2.0×10^9/L，from the first day of chemotherapy, to the time of ANC≥ 2.0×10^9/L, take the median.
The incidence of infection
The incidence of antibiotic use
Incidence of chemotherapy dose adjustment due to neutropenia
Chemotherapy delay time
Incidence of chemotherapy delay caused by neutropenia
The duration of febrile neutropenia in cycles 1 and 2
Full Information
NCT ID
NCT03776604
First Posted
December 10, 2018
Last Updated
December 16, 2018
Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Collaborators
Peking University Cancer Hospital & Institute
1. Study Identification
Unique Protocol Identification Number
NCT03776604
Brief Title
PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy
Official Title
Multi-center, Open, One-arm Clinical Study Evaluating the Efficacy and Safety of Jinyouli (PEGylated Recombinant Human Granulocyte Stimulating Factor, PEG-rhG-CSF) in Preventing Neutropenia After Chemotherapy in Elderly Patients With Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
February 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Collaborators
Peking University Cancer Hospital & Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluation of the efficacy and safety of Jinyouli in preventing neutropenia in multiple chemotherapy cycles in elderly patients with small cell lung cancer through a multicenter, open, one-arm study Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria, chemotherapy regimen: etoposide: 100 mg/m2, d1-3, carboplatin: AUC=5, d1, q21d, prophylactic use test 48 h after chemotherapy Drug PEG-rhG-CSF.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer, PEG-rhG-CSF
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria were prophylactically administered the test drug PEG-rhG-CSF 48 h after chemotherapy.
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PEG-rhG-CSF
Arm Type
Experimental
Arm Description
Jin Youli(PEG-rhG-CSF): The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were <45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle.
Dosing time: 48 h after chemotherapy.
Intervention Type
Drug
Intervention Name(s)
PEG-rhG-CSF
Intervention Description
Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria were prophylactically administered the test drug PEG-rhG-CSF 48 h after chemotherapy.
Jin Youli（PEG-rhG-CSF）: The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were <45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle.
Dosing time: 48 h after chemotherapy.
Primary Outcome Measure Information:
Title
The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
Description
The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
Time Frame
through first cycle of PEG-rhG-CSF,an average of 1 month
Title
The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.
Description
The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.
Time Frame
through second cycle of PEG-rhG-CSF,an average of 1 month
Secondary Outcome Measure Information:
Title
The incidence of febrile neutropenia in cycles 1 and 2
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
through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
Title
The ANC recovery time in cycles 1 and 2
Description
Defined as the patients who appear ANC<2.0×10^9/L，from the first day of chemotherapy, to the time of ANC≥ 2.0×10^9/L, take the median.
Time Frame
through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
Title
The incidence of infection
Time Frame
up to 30 days after the patient study completion
Title
The incidence of antibiotic use
Time Frame
up to 30 days after the patient study completion
Title
Incidence of chemotherapy dose adjustment due to neutropenia
Time Frame
through the study completion,an average of 3 months
Title
Chemotherapy delay time
Time Frame
through the study completion,an average of 3 months
Title
Incidence of chemotherapy delay caused by neutropenia
Time Frame
through the study completion,an average of 3 months
Title
The duration of febrile neutropenia in cycles 1 and 2
Time Frame
through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
Other Pre-specified Outcome Measures:
Title
Incidence and severity of adverse events
Description
All adverse events will be recorded from the time of signing the informed consent form to 30 days after the last dose. Adverse events 30 days after the last dose, only those adverse events associated with the study drug were recorded.
Time Frame
through the study completion,an average of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 70 years old, gender is not limited;
Small cell lung cancer patients diagnosed by histopathology or cytology;
ECOG = 0-1;
The estimated survival period is more than 3 months;
No obvious signs of hematological disease, defined as Hb≥90g/dL, WBC≥4.0×10^9/L, ANC≥2×10^9/L, PLT≥100×10^9/L before enrollment. And no bleeding tendency;
No obvious abnormalities were observed in the electrocardiogram examination;
Liver function tests ALT, AST, TBIL indicators are within 2.5 times the upper limit of normal values. If due to liver metastasis, the above indicators should be within 5 times of the upper limit of normal. If LDH is elevated due to non-tumor causes, LDH should be ≤ 2.5 times the upper limit of normal; if LDH is elevated due to tumor, it can be enrolled;
Renal function test BUN, UA within 1.5 times the upper limit of normal value, creatinine clearance rate> 60ml / min;
Subjects (or their legal representatives/guardians) must sign an informed consent form indicating that they understand the purpose of the study, understand the necessary procedures for the study, and are willing to participate in the study.
Exclusion Criteria:
There are currently uncontrollable infections, body temperature ≥ 38.0 ° C;
Patients with previous malignant tumors that have not been cured or have bone marrow metastasis;
Patients with prophylactic antibiotics;
Accepting other test drugs at the same time or participating in other clinical trials;
Those who are allergic to this product or other genetically engineered E. coli-derived biological products;
The patient has any myelodysplastic and other blood system diseases;
Patients who have received hematopoietic stem cell transplantation or organ transplantation;
The patient has a severe mental or neurological condition that affects informed consent and/or adverse reaction presentation or observation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Zhao, PhD
Phone
86-010-88196456
Email
ohjerry@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hanxiao Chen
Phone
18810526948
Email
Hanxiao0628@163.com
Facility Information:
Facility Name
Bejing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhao, PhD
Phone
86-010-88196456
Email
ohjerry@163.com
12. IPD Sharing Statement
Learn more about this trial
PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy
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