Lifei Xiaoji Wan in Treatment of Advanced NSCLC

Henan University of Traditional Chinese Medicine

Status: Enrolling

Conditions: Advanced Non Small Cell Lung Cancer

Treatments: Other: Conventional treatment with Western medicine; Drug: Lifei Xiaoji Wan

Study type: Interventional

Funder types: Other

Identifiers

NCT06406166

TCM for advanced NSCLC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

trial group

Experimental group

Description:

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

Treatment:

Drug: Lifei Xiaoji Wan

Other: Conventional treatment with Western medicine

control group

No Intervention group

Description:

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