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Clinical Trial Summary

This study including two parts,one part is a randomized clinical trial design,another part is a registration study.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03198117
Study type Interventional
Source Qidong Gaitianli Medicines Co., Ltd
Contact
Status Terminated
Phase N/A
Start date April 25, 2017
Completion date November 23, 2017

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