Clinical trial NCT06406166: Lifei Xiaoji Wan in Treatment of Advanced NSCLC
Official title: Clinical Efficacy of Lifei Xiaoji Wan in Treatment of Advanced NSCLC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Non Small Cell Lung Cancer
Keywords: advanced non small cell lung cancer
traditional Chinese medicine
randomized controlled trial
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 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.
measure: Progression-free survival
timeFrame: 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 outcomes:
measure: Functional Assessment of Cancer Therapy-Lung (FACT-L)
timeFrame: Change from baseline the scores of FACT-L at month 2, 4, 6, 8, 10 and 12.
measure: TCM symptoms and syndrome
timeFrame: Change from baseline the TCM symptoms and syndrome at month 2, 4, 6, 8, 10 and 12.
measure: Response Evaluation Criteria in Solid Tumours (RECIST)
timeFrame: Change from baseline the RECIST at month 2, 4, 6, 8, 10 and 12.
measure: Tumor markers CEA
timeFrame: Change from baseline the levels of tumor markers at month 2, 4, 6, 8, 10 and 12.
measure: Tumor markers CA211
timeFrame: Change from baseline the levels of safety indicators at month 2, 4, 6, 8, 10 and 12.
measure: Tumor markers Squamous Cell Careinoma Antigen
timeFrame: Change from baseline the levels of safety indicators at month 2, 4, 6, 8, 10 and 12.
measure: Complete blood count: White blood cells levels
timeFrame: Change from baseline the levels of white blood cells at month 2, 4, 6, 8, 10 and 12.
measure: Complete blood count: Haemoglobin levels
timeFrame: Change from baseline the levels of levels at month 2, 4, 6, 8, 10 and 12.
measure: Complete blood count: Platelet levels
timeFrame: Change from baseline the levels of Platelet at month 2, 4, 6, 8, 10 and 12.
measure: Liver function: ALT levels
timeFrame: Change from baseline the levels of ALT at month 2, 4, 6, 8, 10 and 12.
measure: Liver function: AST levels
timeFrame: Change from baseline the levels of AST at month 2, 4, 6, 8, 10 and 12.
measure: Renal function: BUN levels
timeFrame: Change from baseline the levels of BUN at month 2, 4, 6, 8, 10 and 12.
measure: Renal function: Cr levels
timeFrame: Change from baseline the levels of Cr at month 2, 4, 6, 8, 10 and 12.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: the First Affiliated Hospital of Henan University of Chinese Medicine
state: Henan
Study officials:
References: