A multicentered, double-blind, randomized study of Fuzheng syndrome differentiation treatment combined with chemotherapy as the first-line treatment of driver mutation-negative advanced NSCLC
- Conditions
- non-small cell lung cancer, NSCLC
- Registration Number
- ITMCTR2000003607
- Lead Sponsor
- onghua Hospital, Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Stage IV NSCLC patients diagnosed by pathology or cytology;
2. Tissue or blood test negative for driver mutation;
3. Did not receive any first-line anti-tumor therapy;
4. TCM syndrome differentiation as Qi deficiency type, Yin deficiency type or Yin deficiency type;
5. Expected survival >= 3 months;
6. Age between 18 and 75 years old (including 18 and 75 years old);
7. PS <= 2 points;
8. The absolute value of neutrophils > 1.5 x10^9/L, PTL > 100 x 10^9/L, Hb > 100mg/dl, liver and kidney function is basically normal;
9. The patient has good compliance, can understand the situation of this study and sign the informed consent form.
1. PD-L1 TPS >= 50%;
2. With serious diseases of other systems;
3. Pregnant or breastfeeding women;
4. With history of uncontrollable mental illness;
5. Allergic to study drugs.
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 Quality of Life;Treg;sPD-L1;1-year survival;