NCT03198117

Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III Non-small Cell Lung Cancer (NSCLC)

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Qidong Gaitianli Medicines Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Huaier Granule	a Chinese traditional medicine
OTHER	placebo	placebo

Timeline

• Start date: 2017-04-25
• Primary completion: 2017-11-23
• Completion: 2017-11-23
• First posted: 2017-06-23
• Last updated: 2020-03-09

Locations

1 site across 1 country: China