Clinical study of Fei-Yan-Ning Granule delaying EGFR-targeted drug resistance for lung cancer
- Conditions
- lung cancer
- Registration Number
- ITMCTR2000003679
- 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) Patients with stage IIIA-IV lung adenocarcinoma confirmed by pathology or cytology or patients with postoperative recurrence and metastasis;
(2) EGFR detected sensitive types (18, 19, 21 exon mutations);
(3) Evaluate the disease progression after 1 month of gefitinib treatment and continue to take it;
(4) TCM syndrome differentiation belongs to the deficiency of essence and qi;
(5) Aged >= 18 years;
(6) Expected survival >= 3 months;
(7) Sign the informed consent.
(1) Other tumor history within 5 years;
(2) Symptomatic brain metastases;
(3) History of cardiovascular disease: Congestive heart failure & GT; Cardiac function level II in NYHA. Patients with unstable angina (angina symptoms at rest) or newly developed angina (beginning in the last 3 months) or myocardial infarction in the last 6 months. Active infection, & GT; Level 2 adverse events (CTC AE.5.0);
(4) Patients during pregnancy or lactation;
(5) Persons with a history of mental illness.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival;Progress Free Survival;
- Secondary Outcome Measures
Name Time Method The quality of life;Serum tumor markers;Disease Control Rate;duration of disease control;TCM clinical syndromes and symptoms;Lymphocyte subtype;