Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Recurrence

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Bone Density Conservation Agents

Hematinics

Vitamins

Leucovorin

Fluorouracil

Levoleucovorin

Oxaliplatin

Calcium

Calcium, Dietary

Hormones

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

Twelve cycles of mFOLFOX6 (oxaliplatin, 85 mg/m²; calcium folinate, 400 mg/m²; 5-fluorouracil, 2800 mg/m²). Patients will be treated with chemotherapy every 2 weeks (+/- 2 days ). Huaier Granule will be administrated from the first cycle of chemotherapy until 48 weeks after surgery or until study termination. Huaier Granule is continuously taken three times per day, 20g per time.

Twelve cycles of mFOLFOX6 (oxaliplatin, 85 mg/m²; calcium folinate, 400 mg/m²; 5-fluorouracil, 2800 mg/m²). Patients will be treated with chemotherapy every 2 weeks (+/- 2 days ).

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

Huaier Granule

Calcium folinate 400 mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1

Calcium folinate

400 mg/m², iv, D1; and 2400mg/m², civ, 48h

5-fluorouracil

Xiaojian Wu, Ph.D.

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.

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

The investigators would like to share the data to the Participating units.

The adverse events were evaluated every 2 weeks; Eastern Cooperative Oncology Group(ECOG) scores, imaging assessment and related biochemical indicators.

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.

OS was defined as the date of definitive surgery until the date of death or the last follow-up.

RFS was defined as the date of definitive surgery until the date of recurrence or death from any cause.

MFS was defined as the date of definitive surgery until the date of metastasis or death from any cause.

Qidong Gaitianli Medicines Co., Ltd

Sixth Affiliated Hospital, Sun Yat-sen University

Prof.

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.

Regular follow-up observation after surgery.

Huaier Granule As Adjuvant Therapy for Colorectal Cancer After Radical Surgery

The adverse events were evaluated every 2 weeks.The adverse events were evaluated with Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adjuvant Chemotherapy Combined With Huaier Granule for Treating High-risk Stage II, Stage III Colorectal Cancer	NCT02785146	Colorectal Canc...	Huaier Granule Oxaliplatin Calcium folinat... 5-fluorouracil	18 Years - 75 Years	Sixth Affiliated Hospital, Sun Yat-sen University
Adjuvant Chemotherapy Combined With Huaier Granule for Treating High-risk Stage II, Stage III Colorectal Cancer	NCT02785146	Colorectal Canc...	Huaier Granule Oxaliplatin Calcium folinat... 5-fluorouracil	18 Years - 75 Years	Sixth Affiliated Hospital, Sun Yat-sen University
Adjuvant Chemotherapy Combined With Huaier Granule for Treating High-risk Stage II, Stage III Colorectal Cancer	NCT02785146	Colorectal Canc...	Huaier Granule Oxaliplatin Calcium folinat... 5-fluorouracil	18 Years - 75 Years	Sixth Affiliated Hospital, Sun Yat-sen University
Huaier Granule As Adjuvant Therapy for Colorectal Cancer After Radical Surgery	NCT02796820	Colorectal Canc...	Huaier Granule	18 Years - 75 Years	Sixth Affiliated Hospital, Sun Yat-sen University

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