Status:
UNKNOWN
Clinical Trial for Post-marketing Evaluation of Sheng Bai Oral Liquid
Lead Sponsor:
BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
Collaborating Sponsors:
Hubei Mon Yan Pharmaceutical Co., Ltd
Conditions:
Non-small-Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2019
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03413358
Start Date
January 15 2018
End Date
October 31 2019
Last Update
January 29 2018
Active Locations (1)
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1
CHINA ACADENY OF CHINESE MEDICAL SCIENCES Guang'anmen Hospital
Beijing, Beijing Municipality, China, 100053