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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
6
a Chinese traditional medicine
placebo
Du Ying Ying
Hefei, Anhui, China
disease-free survival
disease-free survival
Time frame: 2-year
overall survivals
overall survivals
Time frame: 2-year
Quality of Life
Quality of Life-EORTC QLQ-C30
Time frame: 2-year
KPS
Karnofsky
Time frame: 2-year
ECOG-PS
ECOG-PS
Time frame: 2-year
CEA
tumor markers
Time frame: 2-year
CYFRA21-1
tumor markers
Time frame: 2-year
SCC
tumor markers
Time frame: 2-year
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