Non-small Cell Lung Cancer Clinical Trial
Official title:
Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III NSCLC After Postoperative Adjuvant Chemotherapy: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial, Along With a Registration Study
This study including two parts，one part is a randomized clinical trial design，another part is a registration study.
This study include a multicenter, randomized, controlled, double-blind, placebo-controlled
post-market clinical trial and a registration study.
The randomized clinical trial included subjects (n =798) will be randomly divided into
experimental (n = 532) and control groups (n =266) according to a random number table.
Patients in the experimental group will receive Huaier Granule (20g/time, 3 times/d).
Patients in the control group will receive placebo (20g/time, 3 times/d). The registration
study plan to recruitment at least 300 patients.
The primary outcome measures is disease-free survival，secondary outcome measures is 2-year
overall survivals, ECOG-performance status, Karnofsky performance score and tumor markers
(CEA、CYFRA21-1、SCC).
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