Adjuvant Chemotherapy Combined With Huaier Granule for Treating High-risk Stage II, Stage III Colorectal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Adjuvant Chemotherapy Combined With Huaier Granule for Treating High-risk Stage II, Stage III Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Huaier Granule
* Drug: Oxaliplatin
* Drug: Calcium folinate
* Drug: 5-fluorouracil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mFOLFOX6 + Huaier Granule<br>Twelve cycles of mFOLFOX6 (oxaliplatin, 85 mg/m²; calcium folinate, 400 mg/m²; 5-fluorouracil, 2800 mg/m²). Patients will be treated with chemotherapy every 2 weeks (+/- 2 days ). Huaier Granule will be administrated from the first cycle of chemotherapy until 48 weeks after surgery or until study termination. Huaier Granule is continuously taken three times per day, 20g per time. | Drug: Huaier Granule<br>* Huaier Granule is continuously taken three times per day, 20g per time.<br>* Other names: Huaier;Drug: Oxaliplatin<br>* 85 mg/m², ivdrip, D1<br>Drug: Calcium folinate<br>* Calcium folinate 400 mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1<br>* Other names: Calcium levofolinate;Drug: 5-fluorouracil<br>* 400 mg/m², iv, D1; and 2400mg/m², civ, 48h<br>|
| Active Comparator: mFOLFOX6<br>Twelve cycles of mFOLFOX6 (oxaliplatin, 85 mg/m²; calcium folinate, 400 mg/m²; 5-fluorouracil, 2800 mg/m²). Patients will be treated with chemotherapy every 2 weeks (+/- 2 days ). | Drug: Oxaliplatin<br>* 85 mg/m², ivdrip, D1<br>Drug: Calcium folinate<br>* Calcium folinate 400 mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1<br>* Other names: Calcium levofolinate;Drug: 5-fluorouracil<br>* 400 mg/m², iv, D1; and 2400mg/m², civ, 48h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | OS was defined as the date of definitive surgery until the date of death or the last follow-up. | 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. | 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. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Huaier Granule, After radical surgery, Prevention of recurrence and metastasis, Efficacy and safety