Clinical Trial on Ganoderma Spore Lipids Combined With Chemo in Patients With G.I. Cancers
NCT ID: NCT02785523
Last Updated: 2016-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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G. SPORE LIPIDS
Form: Capsule Dosage and frequency: This group receives ganoderma spore lipids capsules 600mg TID in addition to the chemotherapy.
Duration: 6 chemotherapy cycles.
Ganoderma Spore Lipids
Chemotherapy
Placebo
Form: Capsule Dosage and frequency: This group receives placebo capsules 600mg TID in addition to the chemotherapy.
Duration: 6 chemotherapy cycles.
Placebo
Chemotherapy
Interventions
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Ganoderma Spore Lipids
Placebo
Chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis: imaging, cell and pathology report.
* Eastern Cooperative Oncology Group (ECOG) O-2, life expectancy more than 3 months.
* Chemotherapy is not contraindicated.
* No apparent surgical trauma during the previous 2 weeks.
* Past treatment:
* Biological treatment: at least 4 weeks after previous treatment with immunotherapy or other biological; chemotherapy, at least 6 months after last treatment with chemotherapy and or target therapy.
* Surgery: had not received transplantation surgery, at least 2 weeks after last major surgery.
Exclusion Criteria
* Diseases of the blood system.
* Abnormal blood coagulation function.
* Severe brain disease or primary brain tumors without control, and mentally ill person.
* Patients with brain metastases.
* Pregnant or lactating women.
* Patients (male/female) with fertility, But the patients themselves or their spouses do not take effective contraception.
* Allergic constitution.
* In addition, patients taking part in other clinical trials, being treated with other biotherapy or immunotherapy and researchers consider not suitable for clinical subjects for other reasons will be excluded.
18 Years
80 Years
ALL
No
Sponsors
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Xiaonan Cui
OTHER
Responsible Party
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Xiaonan Cui
Professor, Chief Physician
Principal Investigators
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Xiaonan Cui, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Dalian Medical University
Locations
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The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Xiaonan Cui, MD,PhD
Role: primary
Other Identifiers
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G20090400
Identifier Type: -
Identifier Source: org_study_id