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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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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 .

Conditions

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Non-small-Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

These subjects will be randomized (1:1) to treatment group or control group.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

Platinum-based two medicine (carboplatin / cisplatin) plus Sheng Bai oral liquid.

Group Type EXPERIMENTAL

Sheng Bai oral liquid

Intervention Type DRUG

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

Platinum-based two medicine (carboplatin / cisplatin) .

Intervention Type DRUG

Using Platinum-based two medicine (carboplatin / cisplatin)

Control group

Blank control and Platinum-based two medicine (carboplatin / cisplatin) .

Group Type EXPERIMENTAL

Platinum-based two medicine (carboplatin / cisplatin) .

Intervention Type DRUG

Using Platinum-based two medicine (carboplatin / cisplatin)

Interventions

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Sheng Bai oral liquid

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

Platinum-based two medicine (carboplatin / cisplatin) .

Using Platinum-based two medicine (carboplatin / cisplatin)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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 ）.
2. ECOG performance status ≤2.
3. 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.
4. Expected survival period is more than 3 months
5. Subjects join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.

Exclusion Criteria

1. Patients need radiotherapy, targeted therapy, and other anti-cancer therapies during the trial.
2. Patients accepted radiation in the past 4 weeks before enrollment.
3. Previous bone marrow or stem cell transplant, or organ allograft.
4. Recently severe acute infection is not controlled; purulent or chronic infection is present and the wound is not healed.
5. Patients were or being suspected to be allergic to test drugs or related components.
6. 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.
7. Patients with the symptoms of digestive system, such as nausea, vomiting, diarrhea, etc., that are not controlled will influence the test drug.
8. The central nervous system is metastatic and has symptoms.
9. History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma.
10. Patients with severe heart, liver and kidney diseases; serious diseases of hematopoietic system; bleeding tendency.
11. 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.
12. Female patient is pregnant or breast-feeding, and those patients at childbearing age who are not willing to use methods of contraception.
13. Patients who are currently included in other clinical trials or accepted any experimental drugs in the past 4 weeks.
14. Any condition, in the investigator's opinion, is not in the best interest of the subject.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No