A randomized, paralleled control clinical study investigating Huaier Granule for prevention of recurrence and metastasis of colorectal cancer after radical surgery, to evaluate the efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
230
Huaier Granule is continuously taken three times per day, 20g per time.
85 mg/m², ivdrip, D1
Calcium folinate 400 mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGDisease-free survival (DFS)
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.
Time frame: 1 year
Overall survival (OS)
OS was defined as the date of definitive surgery until the date of death or the last follow-up.
Time frame: 5 years
Relapse-free survival (RFS)
RFS was defined as the date of definitive surgery until the date of recurrence or death from any cause.
Time frame: 5 years
Metastasis-free survival (MFS)
MFS was defined as the date of definitive surgery until the date of metastasis or death from any cause.
Time frame: 5 years
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400 mg/m², iv, D1; and 2400mg/m², civ, 48h