Huaier Granule As Adjuvant Therapy for Colorectal Cancer After Radical Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796820
|Contact: Xiaojian Wu, Ph.D.||+firstname.lastname@example.org|
|Sixth Affiliated Hospital, Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510655|
|Contact: Xiaojian Wu, Ph.D. +86-13760608396 email@example.com|
|Principal Investigator:||Xiaojian Wu, Ph.D.||Sixth Affiliated Hospital, Sun Yat-sen University|