Colorectal Cancer
Conditions
Keywords
Huaier Granule, After radical surgery, Prevention of recurrence and metastasis, Efficacy and safety
Brief summary
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.
Interventions
DRUGHuaier Granule
Huaier Granule is continuously taken three times per day, 20g per time.
DRUGOxaliplatin
85 mg/m², ivdrip, D1
DRUGCalcium folinate
Calcium folinate 400 mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1
DRUG5-fluorouracil
400 mg/m², iv, D1; and 2400mg/m², civ, 48h
Sponsors
Qidong Gaitianli Medicines Co., Ltd
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The subjects volunteer to sign the informed consent * Aged: 18 to 75 years old * Colorectal cancer (AJCC-TNM, high-risk Stage II and Stage III) * The diagnosis and colorectal cancer has been confirmed by pathological examination after radical surgery * The liver and kidney function satisfies the following conditions within 15 days after surgery (excluding day 15): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT), alkaline phosphatase (ALP)\< 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \< 1.5 ULN; normal coagulation function * Other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): white blood cells count ≥ 3.0×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109/L * ECOG：0-2 points * No other previous history of malignancy.
Exclusion criteria
* Multiple primary cancer * Not recover from the colorectal surgery * Presence of organ, bone, or skin metastases * Pregnant or lactating women * Those with active bleeding due to various reasons * Those with HIV infection or AIDS-associated diseases * Those with severe acute and chronic diseases * Those with severe diabetes * Those with serious infectious diseases * Those who can not take drugs by oral route * Drug abusers or those with psychological or mental diseases that may interfere with study compliance * Conditions that are considered not suitable for this study investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival (DFS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 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) | 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) | 5 years | MFS was defined as the date of definitive surgery until the date of metastasis or death from any cause. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The effects of Huaier Granule on adverse events of adjuvant chemotherapy. | 6 months | The adverse events were evaluated every 2 weeks; Eastern Cooperative Oncology Group(ECOG) scores, imaging assessment and related biochemical indicators. |
Countries
China
Contacts
Primary ContactXiaojian Wu, Ph.D.
Outcome results
None listed