AzTrials
AzTrials

Non-small-Cell Lung CancerNCT03413358

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

A study testing Sheng Bai oral liquid and Platinum-based two medicine (carboplatin / cisplatin) . in people with Non-small-Cell Lung Cancer, run by BeiJing Yijiayi Medicine Techonoloy Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small-Cell Lung Cancer
What is being tested?
Sheng Bai oral liquid and Platinum-based two medicine (carboplatin / cisplatin) .
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteChina
Study dates
15 Jan 2018to 31 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Hongsheng Lin, Professor contact

010-88001192

drlinhongsheng@163.com

China1 site, 1 recruiting

  • CHINA ACADENY OF CHINESE MEDICAL SCIENCES Guang'anmen Hospital

    Beijing, Beijing Municipality, 100053

    Hongsheng Lin, Professor, 010-88001192, drlinhongsheng@163.com

    Professor

    Recruiting

Other trials in China

About this study

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

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.

Read the 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 .

Being tested
Sheng Bai oral liquid, Platinum-based two medicine (carboplatin / cisplatin) .
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sheng Bai oral liquidDrug

    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) .Drug

    Using Platinum-based two medicine (carboplatin / cisplatin)

Study groups in NCT03413358
Study groupRoleWhat they receive
Treatment groupExperimentalPlatinum-based two medicine (carboplatin / cisplatin) plus Sheng Bai oral liquid.
Receives: Drug: Sheng Bai oral liquid; Drug: Platinum-based two medicine (carboplatin / cisplatin) .
Control groupExperimentalBlank control and Platinum-based two medicine (carboplatin / cisplatin) .
Receives: Drug: Platinum-based two medicine (carboplatin / cisplatin) .

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: six weeks

  2. The recovery time of neutropenia

    Comparison of the recovery time between two groups of Polymorphonuclear neutropenia

    Measured: six weeks

Secondary outcomes (13)

  1. 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.

    Measured: six weeks

  2. 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.

    Measured: six weeks

  3. 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.

    Measured: six weeks

  4. 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.

    Measured: six weeks

  5. 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.

    Measured: six weeks

  6. 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.

    Measured: six weeks

  7. 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.

    Measured: six weeks

  8. 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.

    Measured: six weeks

  9. 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

    Measured: six weeks

  10. 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)

    Measured: six weeks

  11. Cancer-related fatigue

    Comparison of the degree of fatigue changes between two groups before and after treatment.

    Measured: six weeks

  12. rhG-CSF dosage

    Comparison of the rhG-CSF dosage between two groups before and after treatment.

    Measured: six weeks

  13. 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).

    Measured: six weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2018
  2. Study start15 Jan 2018
  3. Primary completion31 Oct 2019 (estimated)
  4. Study completion31 Oct 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
These subjects will be randomized (1:1) to treatment group or control group.
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03413358
Sponsor's protocol ID
2017-133-KY-01
Status last verified
Jan 2018
First submitted
17 Jan 2018
Last updated
29 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Sheng Bai oral liquid and Platinum-based two medicine (carboplatin / cisplatin) . in people with Non-small-Cell Lung Cancer, run by BeiJing Yijiayi Medicine Techonoloy Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hongsheng Lin, Professor (010-88001192, drlinhongsheng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence and degree of neutropenia after chemotherapy (time frame: six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03413358.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in