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Huaier Granule As Adjuvant Therapy for Colorectal Cancer After Radical Surgery

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ClinicalTrials.gov Identifier: NCT02796820
Recruitment Status : Unknown
Verified June 2016 by Xiaojian Wu, Sixth Affiliated Hospital, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : June 13, 2016
Last Update Posted : June 15, 2016
Sponsor:
Collaborator:
Qidong Gaitianli Medicines Co., Ltd
Information provided by (Responsible Party):
Xiaojian Wu, 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Huaier Granule Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Huaier Granule As Adjuvant Therapy for Colorectal Cancer After Radical Surgery
Study Start Date : June 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Huaier Granule
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.
Drug: Huaier Granule
Huaier Granule is continuously taken three times per day, 20g per time.
Other Name: Huaier

No Intervention: Regular follow-up observation
Regular follow-up observation after surgery.



Primary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: 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 :
  1. Overall survival (OS) [ Time Frame: 5 years ]
    OS was defined as the date of definitive surgery until the date of death or the last follow-up.

  2. Relapse-free survival (RFS) [ Time Frame: 5 years ]
    RFS was defined as the date of definitive surgery until the date of recurrence or death from any cause.

  3. Metastasis-free survival (MFS) [ Time Frame: 5 years ]
    MFS was defined as the date of definitive surgery until the date of metastasis or death from any cause.


Other Outcome Measures:
  1. The adverse events of Huaier Granule [ Time Frame: 6 months ]
    The adverse events were evaluated every 2 weeks.The adverse events were evaluated with Common Terminology Criteria for Adverse Events (CTCAE) v4.0.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796820


Contacts
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Contact: Xiaojian Wu, Ph.D. +86-13760608396 wuxjian@mail.sysu.edu.cn

Locations
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China, Guangdong
Sixth Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Xiaojian Wu, Ph.D.    +86-13760608396    wuxjian@mail.sysu.edu.cn   
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Qidong Gaitianli Medicines Co., Ltd
Investigators
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Principal Investigator: Xiaojian Wu, Ph.D. Sixth Affiliated Hospital, Sun Yat-sen University

Publications of Results:
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Responsible Party: Xiaojian Wu, Prof., Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02796820     History of Changes
Other Study ID Numbers: zsly Huaier-2
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators would like to share the data to the Participating units.

Keywords provided by Xiaojian Wu, Sixth Affiliated Hospital, Sun Yat-sen University:
Huaier Granule
After radical surgery
Prevention of Recurrence and Metastasis
Efficacy and safety

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases