Lifei Xiaoji Wan in Treatment of Advanced NSCLC

September 23, 2024 updated by: Henan University of Traditional Chinese Medicine

Clinical Efficacy of Lifei Xiaoji Wan in Treatment of Advanced NSCLC

This study is to evaluate the clinical efficacy of Lifei Xiaoji Wan for advanced non-small cell lung cancer (NSCLC), establish the treatment scheme, and obtain high-quality clinical evidence.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Non-small cell lung cancer (NSCLC) is a disease with high morbidity and mortality, poor prognosis, and a lack of safe and effective treatment. Lifei Xiaoji Wan has significant advantages in the treatment of advanced NSCLC, but the a lack of high-level clinical evaluation evidence and accurate mechanism of action research. According to the previous animal experiments of the team, it was proved that Lifei Xiaoji Wan can significantly inhibit the tumor growth ability of lung cancer mice, and inhibit the proliferation, clonal formation, and migration ability of lung cancer cells. This topic intends to adopt the method of multicenter randomized controlled study to observe the Lifei Xiaoji Wan for advanced NSCLC patients' overall survival (OS), progression-free survival (PFS), Functional Assessment of Cancer Therapy-Lung (FACT-L), TCM symptoms and syndrome and safety, help to clarify the role of Lifei Xiaoji Wan in TCM prevention and treatment of lung cancer, can provide high-level evidence for TCM prevention and treatment of lung cancer research and clinical.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Yuanyuan Wang, MD
  • Phone Number: 0371-66248624
  • Email: 40685685@qq.com

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • the First Affiliated Hospital of Henan University of Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Clinical diagnosis of NSCLC.
  2. The tumor stage (TNM) stage is from III to IV.
  3. 18-80 years old.
  4. The expected survival period is> 3 months.

Exclusion Criteria:

  1. Early-stage patients with prior surgery and no recurrence.
  2. Patients with serious dysfunction of the heart, liver, heart, kidney, and other important organs.
  3. Mental illness and other patients were unable to complete the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: trial group
The patients in the trial group received routine Western medicine treatments, and oral Lifei Xiaoji Wan (10 pills/time, 3 times/day).
Drug: Lifei Xiaoji Wan
The Lifei Xiaoji Wan consists of ginseng, blackhead, rhubarb, aster, forehu, and thin on
Other: Conventional treatment with Western medicine
Conventional treatment with Western medicine
No Intervention: control group
The patients in the control group received routine Western medicine treatments.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
Time from enrollment to patient death.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
Progression-free survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
Time from enrollment to objective tumor progression or all-cause death.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy-Lung (FACT-L)
Time Frame: Change from baseline the scores of FACT-L at month 2, 4, 6, 8, 10 and 12.
Including the physiological status, social / family status, emotional status, functional status and additional concerns, with a total score of 0-144. The higher the score, the more severe the symptoms will be.
Change from baseline the scores of FACT-L at month 2, 4, 6, 8, 10 and 12.
TCM symptoms and syndrome
Time Frame: Change from baseline the TCM symptoms and syndrome at month 2, 4, 6, 8, 10 and 12.
The improvement of the clinical symptoms, such as cough, expectoration, chest tightness, shortness of breath, fatigue, weakness, and loss of appetite.
Change from baseline the TCM symptoms and syndrome at month 2, 4, 6, 8, 10 and 12.
Response Evaluation Criteria in Solid Tumours (RECIST)
Time Frame: Change from baseline the RECIST at month 2, 4, 6, 8, 10 and 12.
patients were collected on Computed Tomography (CT) for imaging analysis and measurement, to observe the changes of tumor bodies and lesions, and to evaluate the efficacy on tumor.
Change from baseline the RECIST at month 2, 4, 6, 8, 10 and 12.
Tumor markers CEA
Time Frame: Change from baseline the levels of tumor markers at month 2, 4, 6, 8, 10 and 12.
Peripheral blood of patients was collected to observe the changes of CEA.
Change from baseline the levels of tumor markers at month 2, 4, 6, 8, 10 and 12.
Tumor markers CA211
Time Frame: Change from baseline the levels of safety indicators at month 2, 4, 6, 8, 10 and 12.
Peripheral blood of patients was collected to observe the changes of CA211.
Change from baseline the levels of safety indicators at month 2, 4, 6, 8, 10 and 12.
Tumor markers Squamous Cell Careinoma Antigen
Time Frame: Change from baseline the levels of safety indicators at month 2, 4, 6, 8, 10 and 12.
Peripheral blood of patients was collected to observe the changes of Squamous Cell Careinoma Antigen.
Change from baseline the levels of safety indicators at month 2, 4, 6, 8, 10 and 12.
Complete blood count: White blood cells levels
Time Frame: Change from baseline the levels of white blood cells at month 2, 4, 6, 8, 10 and 12.
white blood cells levels
Change from baseline the levels of white blood cells at month 2, 4, 6, 8, 10 and 12.
Complete blood count: Haemoglobin levels
Time Frame: Change from baseline the levels of levels at month 2, 4, 6, 8, 10 and 12.
haemoglobin levels
Change from baseline the levels of levels at month 2, 4, 6, 8, 10 and 12.
Complete blood count: Platelet levels
Time Frame: Change from baseline the levels of Platelet at month 2, 4, 6, 8, 10 and 12.
Platelet levels
Change from baseline the levels of Platelet at month 2, 4, 6, 8, 10 and 12.
Liver function: ALT levels
Time Frame: Change from baseline the levels of ALT at month 2, 4, 6, 8, 10 and 12.
ALT levels
Change from baseline the levels of ALT at month 2, 4, 6, 8, 10 and 12.
Liver function: AST levels
Time Frame: Change from baseline the levels of AST at month 2, 4, 6, 8, 10 and 12.
AST levels
Change from baseline the levels of AST at month 2, 4, 6, 8, 10 and 12.
Renal function: BUN levels
Time Frame: Change from baseline the levels of BUN at month 2, 4, 6, 8, 10 and 12.
BUN levels
Change from baseline the levels of BUN at month 2, 4, 6, 8, 10 and 12.
Renal function: Cr levels
Time Frame: Change from baseline the levels of Cr at month 2, 4, 6, 8, 10 and 12.
Cr levels
Change from baseline the levels of Cr at month 2, 4, 6, 8, 10 and 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henan University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TCM for advanced NSCLC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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