Huaier Granule As Adjuvant Therapy for Colorectal Cancer After Radical Surgery
|ClinicalTrials.gov Identifier: NCT02796820|
Recruitment Status : Unknown
Verified June 2016 by Xiaojian Wu, Sixth Affiliated Hospital, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : June 13, 2016
Last Update Posted : June 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Huaier Granule||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Huaier Granule As Adjuvant Therapy for Colorectal Cancer After Radical Surgery|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: Huaier Granule
Huaier Granule will be administrated from 4 to 48 weeks after surgery or until study termination. Huaier Granule is continuously taken three times per day, 20g per time.
Drug: Huaier Granule
Huaier Granule is continuously taken three times per day, 20g per time.
Other Name: Huaier
No Intervention: Regular follow-up observation
Regular follow-up observation after surgery.
- Disease-free survival (DFS) [ Time Frame: 1 year ]DFS was defined as the date of definitive surgery until the date of recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first.
- Overall survival (OS) [ Time Frame: 5 years ]OS was defined as the date of definitive surgery until the date of death or the last follow-up.
- Relapse-free survival (RFS) [ Time Frame: 5 years ]RFS was defined as the date of definitive surgery until the date of recurrence or death from any cause.
- Metastasis-free survival (MFS) [ Time Frame: 5 years ]MFS was defined as the date of definitive surgery until the date of metastasis or death from any cause.
- The adverse events of Huaier Granule [ Time Frame: 6 months ]The adverse events were evaluated every 2 weeks.The adverse events were evaluated with Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796820
|Contact: Xiaojian Wu, Ph.D.||+email@example.com|
|Sixth Affiliated Hospital, Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510655|
|Contact: Xiaojian Wu, Ph.D. +86-13760608396 firstname.lastname@example.org|
|Principal Investigator:||Xiaojian Wu, Ph.D.||Sixth Affiliated Hospital, Sun Yat-sen University|