Huaier Granule As Adjuvant Therapy for Colorectal Cancer After Radical Surgery

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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Huaier Granule As Adjuvant Therapy for Colorectal Cancer After Radical Surgery

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Huaier Granule


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, Stage Ⅰ, low-risk Stage Ⅱand Stage Ⅲ; Patients with Stage Ⅲ colorectal cancer refuse to postoperative adjuvant chemotherapy); 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: Huaier Granule<br>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<br>* Huaier Granule is continuously taken three times per day, 20g per time.<br>* Other names: Huaier;|
| No Intervention: Regular follow-up observation<br>Regular follow-up observation after surgery. | |

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