Back to resultsClinical Trial for Post-marketing Evaluation of Sheng Bai Oral Liquid
Primary Purpose
Non-small-Cell Lung Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sheng Bai oral liquid
Platinum-based two medicine (carboplatin / cisplatin) .
Sponsored by
About this trial
This is an interventional treatment trial for Non-small-Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients who are confirmed no small cell lung cancer in accordance with the clinical diagnostic criteria , or by pathological histology or cytology examination which investigators think are suitable to accept The platinum-based doublet chemotherapy（According to RECIST V1.1,patients with no small cell cancers should have one measurable lesions at least ）.
- ECOG performance status ≤2.
- Laboratory inspection basically meets the following requirements： 1)Blood test：a. WBC≥ 4.0×109/L, b. ANC≥2.0×109/L, c. PLT≥100×109/L. 2)Biochemical test：a. ALT≤2.5 times the ULN;b. AST≤2.5 times the ULN ;c. Cr<=1.5 times the ULN.
- Expected survival period is more than 3 months
- Subjects join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.
Exclusion Criteria:
- Patients need radiotherapy, targeted therapy, and other anti-cancer therapies during the trial.
- Patients accepted radiation in the past 4 weeks before enrollment.
- Previous bone marrow or stem cell transplant, or organ allograft.
- Recently severe acute infection is not controlled; purulent or chronic infection is present and the wound is not healed.
- Patients were or being suspected to be allergic to test drugs or related components.
- Patients with hypersplenism, hyperthyroidism, adrenal cortical hypofunction, connective tissue disease, infectious diseases, such as viral hepatitis, tuberculosis infection and other diseases which can lead to the decrease of the white blood cells at the same time.
- Patients with the symptoms of digestive system, such as nausea, vomiting, diarrhea, etc., that are not controlled will influence the test drug.
- The central nervous system is metastatic and has symptoms.
- History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma.
- Patients with severe heart, liver and kidney diseases; serious diseases of hematopoietic system; bleeding tendency.
- Patients have a history of drug abuse and cannot be reined ;Patients with symptomatic, uncontrolled nervous disorders, mental illness or psychiatric disorder have less compliance.
- Female patient is pregnant or breast-feeding, and those patients at childbearing age who are not willing to use methods of contraception.
- Patients who are currently included in other clinical trials or accepted any experimental drugs in the past 4 weeks.
- Any condition, in the investigator's opinion, is not in the best interest of the subject.
Sites / Locations
- CHINA ACADENY OF CHINESE MEDICAL SCIENCES Guang'anmen HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment group
Control group
Arm Description
Platinum-based two medicine (carboplatin / cisplatin) plus Sheng Bai oral liquid.
Blank control and Platinum-based two medicine (carboplatin / cisplatin) .
Outcomes
Primary Outcome Measures
The incidence and degree of neutropenia after chemotherapy
Comparison of the incidence and extent of neutrophil reduction in two chemotherapy cycles between two groupschemotherapy cycles between two groups according to CTC AE4.03,as well as the recovery time of neutropenia
The recovery time of neutropenia
Comparison of the recovery time between two groups of Polymorphonuclear neutropenia
Secondary Outcome Measures
The incidence of neutropenia associated with Fever (FN) in patients after chemotherapy
Comparison of the incidence of fever with neutropenia in two chemotherapy cycles between two groups.
The incidence of Peripheral blood thrombocytopenia disease
Comparison of the incidence and duration of thrombocytopenia in two chemotherapy cycles between the two groups according to CTC AE4.03.
The duration of Peripheral blood thrombocytopenia disease
Comparison of the incidence and duration of thrombocytopenia in two chemotherapy cycles between the two groups according to CTC AE4.03.
THE incidence and duration of hemoglobin reduction in peripheral blood
Comparison of the incidence and duration of haemoglobin reduction in two chemotherapy cycles between two groups according to CTC AE4.03.
THE duration of hemoglobin reduction in peripheral blood
Comparison of the incidence and duration of haemoglobin reduction in two chemotherapy cycles between two groups according to CTC AE4.03.
THE incidence and duration of peripheral blood leukocyte reduction
Comparison of the incidence and duration of leukopenia in two chemotherapy cycles between the two groups according to CTC AE4.03.
The duration of peripheral blood leukocyte reduction
Comparison of the incidence and duration of leukopenia in two chemotherapy cycles between the two groups according to CTC AE4.03.
The time when the neutrophils were reduced to the lowest point after chemotherapy
Comparison of the time when the neutrophils were reduced to the lowest point after chemotherapy in two chemotherapy cycles between the two groups.
Neutrophil value of neutrophils in patients with low to lowest level after chemotherapy
Comparison of neutrophil values between two groups when neutrophils were reduced to the lowest point after chemotherapy
MDASI-TCM
Comparison of the TCM syndrome score changes between two groups before and after treatment.(if you want see the scale information ,you can reference to the link:https://www.mdanderson.org/content/dam/mdanderson/documents/Departments-and-Divisions/Symptom-Research/MDASI-TCM_SAMPLE.pdf)
Cancer-related fatigue
Comparison of the degree of fatigue changes between two groups before and after treatment.
rhG-CSF dosage
Comparison of the rhG-CSF dosage between two groups before and after treatment.
Immune Index (optional)
Observed indicators include IL-2, INF, NK cells, CD4 +, CD8 +, divided according to the results increased(After treatment than before treatment to improve ≥ 10%, or returned to normal by the abnormalities), decreased(After treatment than before treatment decreased ≥ 10%, or from normal to abnormal changes), stable(After treatment than before treatment, decreased less than 10% or maintained within the normal range).
Full Information
NCT ID
NCT03413358
First Posted
January 17, 2018
Last Updated
January 22, 2018
Sponsor
BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
Collaborators
Hubei Mon Yan Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03413358
Brief Title
Clinical Trial for Post-marketing Evaluation of Sheng Bai Oral Liquid
Official Title
A Randomized, Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Sheng Bai Oral Liquid in Prevention and Treatment for The Decrease of Neutrophils After Chemotherapy in Patients With Non-Small-Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
October 31, 2019 (Anticipated)
Study Completion Date
October 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
Collaborators
Hubei Mon Yan Pharmaceutical Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of Sheng Bai oral liquid in prevention and treatment of the decrease of neutrophilics after chemotherapy in patients with non-small-cell lung cancer.
Detailed Description
The Clinical trail is a multicenter, prospective, randomized controlled study. The planned sample size is 240 subjects. These subjects will be randomized (1:1) to treatment group (Platinum-based two medicine (carboplatin / cisplatin) plus Sheng Bai oral liquid) or control group ( Platinum-based two medicine (carboplatin / cisplatin) plus blank control). The study population includes the patients with non-small-cell lung cancer .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small-Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
These subjects will be randomized (1:1) to treatment group or control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Platinum-based two medicine (carboplatin / cisplatin) plus Sheng Bai oral liquid.
Arm Title
Control group
Arm Type
Experimental
Arm Description
Blank control and Platinum-based two medicine (carboplatin / cisplatin) .
Intervention Type
Drug
Intervention Name(s)
Sheng Bai oral liquid
Intervention Description
Drug: Sheng Bai oral liquid 40 mL, oral use, thrice daily after screening on the same day in the second course of the chemotherapy.
Subjects will be treated for 2 courses
Intervention Type
Drug
Intervention Name(s)
Platinum-based two medicine (carboplatin / cisplatin) .
Intervention Description
Using Platinum-based two medicine (carboplatin / cisplatin)
Primary Outcome Measure Information:
Title
The incidence and degree of neutropenia after chemotherapy
Description
Comparison of the incidence and extent of neutrophil reduction in two chemotherapy cycles between two groupschemotherapy cycles between two groups according to CTC AE4.03,as well as the recovery time of neutropenia
Time Frame
six weeks
Title
The recovery time of neutropenia
Description
Comparison of the recovery time between two groups of Polymorphonuclear neutropenia
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
The incidence of neutropenia associated with Fever (FN) in patients after chemotherapy
Description
Comparison of the incidence of fever with neutropenia in two chemotherapy cycles between two groups.
Time Frame
six weeks
Title
The incidence of Peripheral blood thrombocytopenia disease
Description
Comparison of the incidence and duration of thrombocytopenia in two chemotherapy cycles between the two groups according to CTC AE4.03.
Time Frame
six weeks
Title
The duration of Peripheral blood thrombocytopenia disease
Description
Comparison of the incidence and duration of thrombocytopenia in two chemotherapy cycles between the two groups according to CTC AE4.03.
Time Frame
six weeks
Title
THE incidence and duration of hemoglobin reduction in peripheral blood
Description
Comparison of the incidence and duration of haemoglobin reduction in two chemotherapy cycles between two groups according to CTC AE4.03.
Time Frame
six weeks
Title
THE duration of hemoglobin reduction in peripheral blood
Description
Comparison of the incidence and duration of haemoglobin reduction in two chemotherapy cycles between two groups according to CTC AE4.03.
Time Frame
six weeks
Title
THE incidence and duration of peripheral blood leukocyte reduction
Description
Comparison of the incidence and duration of leukopenia in two chemotherapy cycles between the two groups according to CTC AE4.03.
Time Frame
six weeks
Title
The duration of peripheral blood leukocyte reduction
Description
Comparison of the incidence and duration of leukopenia in two chemotherapy cycles between the two groups according to CTC AE4.03.
Time Frame
six weeks
Title
The time when the neutrophils were reduced to the lowest point after chemotherapy
Description
Comparison of the time when the neutrophils were reduced to the lowest point after chemotherapy in two chemotherapy cycles between the two groups.
Time Frame
six weeks
Title
Neutrophil value of neutrophils in patients with low to lowest level after chemotherapy
Description
Comparison of neutrophil values between two groups when neutrophils were reduced to the lowest point after chemotherapy
Time Frame
six weeks
Title
MDASI-TCM
Description
Comparison of the TCM syndrome score changes between two groups before and after treatment.(if you want see the scale information ,you can reference to the link:https://www.mdanderson.org/content/dam/mdanderson/documents/Departments-and-Divisions/Symptom-Research/MDASI-TCM_SAMPLE.pdf)
Time Frame
six weeks
Title
Cancer-related fatigue
Description
Comparison of the degree of fatigue changes between two groups before and after treatment.
Time Frame
six weeks
Title
rhG-CSF dosage
Description
Comparison of the rhG-CSF dosage between two groups before and after treatment.
Time Frame
six weeks
Title
Immune Index (optional)
Description
Observed indicators include IL-2, INF, NK cells, CD4 +, CD8 +, divided according to the results increased(After treatment than before treatment to improve ≥ 10%, or returned to normal by the abnormalities), decreased(After treatment than before treatment decreased ≥ 10%, or from normal to abnormal changes), stable(After treatment than before treatment, decreased less than 10% or maintained within the normal range).
Time Frame
six weeks
Other Pre-specified Outcome Measures:
Title
Genetic Testing
Description
The changes of body index before and after treatment were compared between two groups of subjects.
Time Frame
six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are confirmed no small cell lung cancer in accordance with the clinical diagnostic criteria , or by pathological histology or cytology examination which investigators think are suitable to accept The platinum-based doublet chemotherapy（According to RECIST V1.1,patients with no small cell cancers should have one measurable lesions at least ）.
ECOG performance status ≤2.
Laboratory inspection basically meets the following requirements： 1)Blood test：a. WBC≥ 4.0×109/L, b. ANC≥2.0×109/L, c. PLT≥100×109/L. 2)Biochemical test：a. ALT≤2.5 times the ULN;b. AST≤2.5 times the ULN ;c. Cr<=1.5 times the ULN.
Expected survival period is more than 3 months
Subjects join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.
Exclusion Criteria:
Patients need radiotherapy, targeted therapy, and other anti-cancer therapies during the trial.
Patients accepted radiation in the past 4 weeks before enrollment.
Previous bone marrow or stem cell transplant, or organ allograft.
Recently severe acute infection is not controlled; purulent or chronic infection is present and the wound is not healed.
Patients were or being suspected to be allergic to test drugs or related components.
Patients with hypersplenism, hyperthyroidism, adrenal cortical hypofunction, connective tissue disease, infectious diseases, such as viral hepatitis, tuberculosis infection and other diseases which can lead to the decrease of the white blood cells at the same time.
Patients with the symptoms of digestive system, such as nausea, vomiting, diarrhea, etc., that are not controlled will influence the test drug.
The central nervous system is metastatic and has symptoms.
History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma.
Patients with severe heart, liver and kidney diseases; serious diseases of hematopoietic system; bleeding tendency.
Patients have a history of drug abuse and cannot be reined ;Patients with symptomatic, uncontrolled nervous disorders, mental illness or psychiatric disorder have less compliance.
Female patient is pregnant or breast-feeding, and those patients at childbearing age who are not willing to use methods of contraception.
Patients who are currently included in other clinical trials or accepted any experimental drugs in the past 4 weeks.
Any condition, in the investigator's opinion, is not in the best interest of the subject.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongsheng Lin, Professor
Phone
010-88001192
Email
drlinhongsheng@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongsheng Lin, Professor
Organizational Affiliation
CHINA ACADENY OF CHINESE MEDICAL SCIENCES Guang'anmen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHINA ACADENY OF CHINESE MEDICAL SCIENCES Guang'anmen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongsheng Lin, Professor
Phone
010-88001192
Email
drlinhongsheng@163.com
First Name & Middle Initial & Last Name & Degree
Professor
12. IPD Sharing Statement
Links:
URL
http://xueshu.baidu.com/s?wd=paperuri%3A%288f20f17d60dfadfbf49bfa72eef1dc38%29&filter=sc_long_sign&tn=SE_xueshusource_2kduw22v&sc_vurl=http%3A%2F%2Fdoi.med.wanfangdata.com.cn%2Fqk%2Fzhzl201501014&ie=utf-8&sc_us=1930548602497734534
Description
Standards for the diagnosis and treatment of primary lung cancer (2015 version) in China
URL
http://www.nccnchina.org/nccn-guidelines-china.aspx
Description
NCCN Guidelines® : China Editions
Learn more about this trial
Clinical Trial for Post-marketing Evaluation of Sheng Bai Oral Liquid
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