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

• 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
• Treatments: Calcium; Calcium, Dietary; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

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