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

Phase 3

• Conditions: Colorectal Cancer
• Interventions: Drug: Huaier Granule; Drug: Oxaliplatin; Drug: Calcium folinate; Drug: 5-fluorouracil

• Registration Number: NCT02785146
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-05-27
• Status Verified: 2016-06
• Study Start: 2016-06
• Last Update Submitted: 2016-06-07
• Last Update Posted: 2016-06-08
• Primary Completion: 2018-01
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mFOLFOX6 + Huaier Granule	Huaier Granule	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.
mFOLFOX6 + Huaier Granule	Oxaliplatin	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.
mFOLFOX6 + Huaier Granule	Calcium folinate	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.
mFOLFOX6	Calcium folinate	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 ).
mFOLFOX6 + Huaier Granule	5-fluorouracil	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.
mFOLFOX6	Oxaliplatin	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 ).
mFOLFOX6	5-fluorouracil	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 ).

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Relapse-free survival (RFS)	5 years	RFS was defined as the date of definitive surgery until the date of recurrence or death from any cause.
Metastasis-free survival (MFS)	5 years	MFS was defined as the date of definitive surgery until the date of metastasis or death from any cause.
Overall survival (OS)	5 years	OS was defined as the date of definitive surgery until the date of death or the last follow-up.

Trial Locations

Locations (1)

Sixth Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China