Clinical trial
Clinical Efficacy of Lifei Xiaoji Wan in Treatment of Advanced NSCLC
Name
TCM for advanced NSCLC
Description
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.
Trial arms
Trial start
2022-06-01
Estimated PCD
2024-10-01
Trial end
2024-12-31
Status
Recruiting
Treatment
Lifei Xiaoji Wan
The Lifei Xiaoji Wan consists of ginseng, blackhead, rhubarb, aster, forehu, and thin on
Arms:
trial group
Conventional treatment with Western medicine
Conventional treatment with Western medicine
Arms:
trial group
Size
100
Primary endpoint
Overall survival
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
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.
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-05-09
1 organization
1 product
1 indication
Organization
Henan University of Traditional Chinese MedicineProduct
Lifei Xiaoji WanIndication
NSCLC