A randomized controlled study of Yiqi Chutan Fa (Yifei Sanjie Wan) combined with platinum doublets for the treatment of mid and advanced Non-small Cell Lung Cancer in newly patients with driver gene-negative
- Conditions
- on-small Cell Lung Cancer
- Registration Number
- ITMCTR2100004439
- Lead Sponsor
- The First Affiliated Hospital of Guangzhou University of Traditonal Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients who are new confirmed as Non-small Cell Lung Cancer by histopathology and/or cytopathology can use chemotherapy as primary treatment.
2. Men and women range in age from 18-75 years.
3. The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score is 0-2.
4. Lifetime is expected to be 3 months or more.
5. Patients at least have one measurable target lesion examined by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
6. Informed consent form is signed willingly by all study participants.
1. The result of genetic testing is positive for one of the three biomarkers (Epidermal growth factor receptor [EGFR], Anaplastic lymphoma kinase [ALK] and c-ros oncogene receptor kinase [ROS]).
2. They are intended to immunotherapy.
3. They are intended to radiotherapy.
4. The status of brain metastasis (BM) is unstable.
5. Pregnant women or breast feeding women.
6. Mental illness or mental retardation.
7. Patients are intolerance or allergic to study drug.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival;
- Secondary Outcome Measures
Name Time Method Overall Survival;Disease Control Rate;One-year survival rate;The duration of drug use;Quality of Life;Objective Response Rate;