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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Huaier Granule
Oxaliplatin
Calcium folinate
5-fluorouracil
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Huaier Granule, After radical surgery, Prevention of recurrence and metastasis, Efficacy and safety

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mFOLFOX6 + Huaier Granule

mFOLFOX6

Arm Description

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 ).

Outcomes

Primary Outcome Measures

Disease-free survival (DFS)
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

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

Full Information

First Posted
May 19, 2016
Last Updated
June 7, 2016
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators
Qidong Gaitianli Medicines Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02785146
Brief Title
Adjuvant Chemotherapy Combined With Huaier Granule for Treating High-risk Stage II, Stage III Colorectal Cancer
Official Title
Adjuvant Chemotherapy Combined With Huaier Granule for Treating High-risk Stage II, Stage III Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators
Qidong Gaitianli Medicines Co., Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Huaier Granule, After radical surgery, Prevention of recurrence and metastasis, Efficacy and safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mFOLFOX6 + Huaier Granule
Arm Type
Experimental
Arm Description
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.
Arm Title
mFOLFOX6
Arm Type
Active Comparator
Arm Description
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 ).
Intervention Type
Drug
Intervention Name(s)
Huaier Granule
Other Intervention Name(s)
Huaier
Intervention Description
Huaier Granule is continuously taken three times per day, 20g per time.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
85 mg/m², ivdrip, D1
Intervention Type
Drug
Intervention Name(s)
Calcium folinate
Other Intervention Name(s)
Calcium levofolinate
Intervention Description
Calcium folinate 400 mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Intervention Description
400 mg/m², iv, D1; and 2400mg/m², civ, 48h
Primary Outcome Measure Information:
Title
Disease-free survival (DFS)
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
OS was defined as the date of definitive surgery until the date of death or the last follow-up.
Time Frame
5 years
Title
Relapse-free survival (RFS)
Description
RFS was defined as the date of definitive surgery until the date of recurrence or death from any cause.
Time Frame
5 years
Title
Metastasis-free survival (MFS)
Description
MFS was defined as the date of definitive surgery until the date of metastasis or death from any cause.
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
The effects of Huaier Granule on adverse events of adjuvant chemotherapy.
Description
The adverse events were evaluated every 2 weeks; Eastern Cooperative Oncology Group(ECOG) scores, imaging assessment and related biochemical indicators.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojian Wu, Ph.D.
Phone
+86-13760608396
Email
wuxjian@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojian Wu, Ph.D.
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sixth Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojian Wu, Ph.D.
Phone
+86-13760608396
Email
wuxjian@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators would like to share the data to the Participating units.
Citations:
PubMed Identifier
20718753
Citation
Zhang N, Kong X, Yan S, Yuan C, Yang Q. Huaier aqueous extract inhibits proliferation of breast cancer cells by inducing apoptosis. Cancer Sci. 2010 Nov;101(11):2375-83. doi: 10.1111/j.1349-7006.2010.01680.x.
Results Reference
result
PubMed Identifier
22895629
Citation
Wang X, Zhang N, Huo Q, Yang Q. Anti-angiogenic and antitumor activities of Huaier aqueous extract. Oncol Rep. 2012 Oct;28(4):1167-75. doi: 10.3892/or.2012.1961. Epub 2012 Aug 8.
Results Reference
result
PubMed Identifier
23599758
Citation
Zhang T, Wang K, Zhang J, Wang X, Chen Z, Ni C, Qiu F, Huang J. Huaier aqueous extract inhibits colorectal cancer stem cell growth partially via downregulation of the Wnt/beta-catenin pathway. Oncol Lett. 2013 Apr;5(4):1171-1176. doi: 10.3892/ol.2013.1145. Epub 2013 Jan 21.
Results Reference
result
PubMed Identifier
25077927
Citation
Wang X, Zhang N, Huo Q, Sun M, Dong L, Zhang Y, Xu G, Yang Q. Huaier aqueous extract inhibits stem-like characteristics of MCF7 breast cancer cells via inactivation of hedgehog pathway. Tumour Biol. 2014 Nov;35(11):10805-13. doi: 10.1007/s13277-014-2390-2. Epub 2014 Jul 31.
Results Reference
result

Learn more about this trial

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

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