Huaier Granule As Adjuvant Therapy for Colorectal Cancer After Radical Surgery

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: Huaier Granule

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02796820

zsly Huaier-2

Details and patient eligibility

About

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.

Enrollment: 230 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Huaier Granule

Experimental group

Description:

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.

Treatment:

Drug: Huaier Granule

Regular follow-up observation

No Intervention group

Description:

Regular follow-up observation after surgery.