Non-small cell lung cancer
Conditions
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1. Patients with stage IIIB or IV lung adenocarcinoma without chemotherapy confirmed by pathology or cytology carried EGFR gene mutations, including exon 19 deletion mutation (19del) and exon 21 point mutation (21l858r). 2. The patients who had been treated with EGFR-TKI for more than 3 months showed a rapid increase in tumor load and symptom score = 3 months; 7. For patients without major organ dysfunction, blood routine test, liver, kidney and heart function meet the following requirements: hemoglobin >= 120g / L, absolute neutrophil count (ANC) >= 1.5 * 10^9 / L, platelet >= 80 * 10^9 / L, bilirubin <= 1.5uln, alkaline phosphatase (AP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 * ULN. INR <= 1.5, creatinine <= 1.5uln.
Exclusion criteria
Exclusion criteria: 1. Patients with other tumor history within 5 years; 2. Those who carry T790M mutation and plan to use EGFR-TKI third generation drugs or meet the second-line targeted therapy and immunotherapy; 3. Patients who have a history of radiotherapy and are ready to receive radiotherapy in recent 2 months 4. Symptomatic brain metastases; 5. Those who have been or are participating in other clinical studies; 6. History of cardiovascular disease: congestive heart failure > NYHA class II. Patients with unstable angina (angina symptoms resting) or new onset angina (starting in the last 3 months) or myocardial infarction occurred in the past 6 months. Active infection, > grade 2 adverse events (CTC AE. 5.0); 7. Pregnant or lactating patients; 8. Patients with uncontrollable mental history.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;FACT-L;LCSS; | — |
Countries
China
Contacts
Public ContactLing Xu
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed