Huaier Granule As Adjuvant Therapy for Colorectal Cancer After Radical Surgery

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Collaborator: Qidong Gaitianli Medicines Co., Ltd

Criteria

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.