Clinical Trial for Post-marketing Evaluation of Sheng Bai Oral Liquid

Study Overview
=================
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 .

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

Conditions
-----------------
Non-small-Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Sheng Bai oral liquid
* Drug: Platinum-based two medicine (carboplatin / cisplatin) .


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: These subjects will be randomized (1:1) to treatment group or control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Platinum-based two medicine (carboplatin / cisplatin) plus Sheng Bai oral liquid. | Drug: Sheng Bai oral liquid<br>* 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<br>Drug: Platinum-based two medicine (carboplatin / cisplatin) .<br>* Using Platinum-based two medicine (carboplatin / cisplatin)<br>|
| Experimental: Control group<br>Blank control and Platinum-based two medicine (carboplatin / cisplatin) . | Drug: Platinum-based two medicine (carboplatin / cisplatin) .<br>* Using Platinum-based two medicine (carboplatin / cisplatin)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | six weeks | 
| The recovery time of neutropenia | Comparison of the recovery time between two groups of Polymorphonuclear neutropenia | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | six weeks | 
| 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. | six weeks | 
| 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. | six weeks | 
| 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. | six weeks | 
| 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. | six weeks | 
| 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. | six weeks | 
| 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. | six weeks | 
| 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. | six weeks | 
| 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 | six weeks | 
| 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) | six weeks | 
| Cancer-related fatigue | Comparison of the degree of fatigue changes between two groups before and after treatment. | six weeks | 
| rhG-CSF dosage | Comparison of the rhG-CSF dosage between two groups before and after treatment. | six weeks | 
| 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). | six weeks |