Lifei Xiaoji Wan in Treatment of Advanced NSCLC

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

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Advanced Non Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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trial group

The patients in the trial group received routine Western medicine treatments, and oral Lifei Xiaoji Wan (10 pills/time, 3 times/day).

Group Type EXPERIMENTAL

Lifei Xiaoji Wan

Intervention Type DRUG

The Lifei Xiaoji Wan consists of ginseng, blackhead, rhubarb, aster, forehu, and thin on

Conventional treatment with Western medicine

Intervention Type OTHER

Conventional treatment with Western medicine

control group

The patients in the control group received routine Western medicine treatments.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifei Xiaoji Wan

The Lifei Xiaoji Wan consists of ginseng, blackhead, rhubarb, aster, forehu, and thin on

Intervention Type DRUG

Conventional treatment with Western medicine

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No