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Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery

Sponsor
Qidong Gaitianli Medicines Co., Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02975661
Collaborator
(none)
840
Enrollment
1
Location
59.9
Duration (Months)
14
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Registration of patients after gastrointestinal cancer radical surgery, including the information of treatments, recurrence & metastasis, adverse events,etc.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    840 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery
    Study Start Date :
    Nov 1, 2016
    Actual Primary Completion Date :
    Jun 30, 2017
    Anticipated Study Completion Date :
    Oct 30, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Observational 1

    Huaier Granule
    Observational 2

    Radiotherapy or chemotherapy
    Observational 3

    treatment abandoned
    Observational 4

    Huaier Granule & Radiotherapy or chemotherapy

    Outcome Measures

    Primary Outcome Measures

    1. Disease free survival (DFS) [Up to 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients with gastrointestinal cancer (stomach, colon or rectum);

    2. Patients who have received gastrointestinal cancer radical surgery within a month;

    3. Patients between 18 and 70 years old,no gender restriction;

    4. Patients volunteer to participate this study and have signed the informed consent form.

    Exclusion Criteria:

    1. No chemotherapy or combined radiation and chemotherapy indications；

    2. Unable to cooperate to complete related information collection;

    3. Participation in any other clinical trial within three months;

    4. Conditions that are considered not suitable for this study investigators.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 LU Qidong Anhui China

    Sponsors and Collaborators

    • Qidong Gaitianli Medicines Co., Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qidong Gaitianli Medicines Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT02975661
    Other Study ID Numbers:
    • HE-201601
    First Posted:
    Nov 29, 2016
    Last Update Posted:
    Dec 16, 2020
    Last Verified:
    Dec 1, 2020
    Additional relevant MeSH terms:
    Gastrointestinal Neoplasms
    Recurrence

    Study Results

    No Results Posted as of Dec 16, 2020