Huaier Granule As Adjuvant Therapy for Colorectal Cancer After Radical Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-06-30

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.

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Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Huaier Granule

Intervention Type DRUG

Huaier Granule is continuously taken three times per day, 20g per time.

Regular follow-up observation

Regular follow-up observation after surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Huaier Granule

Huaier Granule is continuously taken three times per day, 20g per time.

Intervention Type DRUG

Other Intervention Names

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Huaier

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No