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Clinical Trial of Cinobufacini Injection Combined With Oxaliplatin Regimen on Gastrointestine Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860429
Recruitment Status : Unknown
Verified August 2016 by Xiaonan Cui, The First Affiliated Hospital of Dalian Medical University.
Recruitment status was:  Not yet recruiting
First Posted : August 9, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Xiaonan Cui, The First Affiliated Hospital of Dalian Medical University

Brief Summary:
The clinical trail of Cinobufacini injection combined with Oxaliplatin regimen on gastrointestine carcinoma.This trail is randomized controled.Patients are diagnosed gastrointestinal cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive Oxaliplatin regimen.The treatment group receives Cinobufotalin 20ml mixed with 5% Glucose injection 500ml from the first day of chemotherapy until seven days in addition to the chemotherapy.The control group only receive the same chemotherapy with the treatment group.Both group have the same adjuvant therapy.Mainly to study of oxaliplatin into Cinobufacini injection leads to the influence of the peripheral nerve toxicity.Clinical evaluation includes neural electrophysiological test,chemotherapy drug toxicities,quality of life(QOL),etc.Blood biochemistry tests mainly include inflammatory cytokines,peroxidase reaction,immune cell number ratio and stress hormone,etc.

Condition or disease Intervention/treatment Phase
Gastrointestinal Neoplasms Drug: Cinobufacini injection Drug: chemotherapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2016
Estimated Primary Completion Date : September 2017

Arm Intervention/treatment
Experimental: Cinobufacini injection

Capsule Dosage and frequency:This group receives cinobufacini injection 20ml mixed with 5% Glucose injection 500ml started at the first day of chemotherapy until seven days once a day.

Duration:6 chemotherapy cycles.

Drug: Cinobufacini injection
cinobufacini injection 20ml mixed with 5% Glucose injection 500ml started at the first day of chemotherapy until seven days once a day.

Drug: chemotherapy
Chemotherapy is the oxaliplatin combination with fluorouracil regimen.

Control group
Only receive the same chemotherapy with the experimental groups.No Cinobufacini injection.And have the same adjuvant treatment with the experimental groups.
Drug: chemotherapy
Chemotherapy is the oxaliplatin combination with fluorouracil regimen.




Primary Outcome Measures :
  1. neural electrophysiological test [ Time Frame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),up to 6 months ]

Secondary Outcome Measures :
  1. The quality of life questionnaire(QLQ)-C30 [ Time Frame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months ]
  2. National Cancer Institute(NCI)Common Toxicity Criteria [ Time Frame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months ]
  3. Levi sensory nerve toxicity classification standard [ Time Frame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months ]
  4. image test [ Time Frame: For adjuvant chemotherapy patients every 3 months.For saving chemotherapy patients every 2 months.anticipate up to 1 years. ]
  5. inflammatory cytokines,in blood. [ Time Frame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months ]
    For example:Interleukin(IL)-6,tumor necrosis factor(TNF)etc,in bood

  6. peroxidase reaction,in blood. [ Time Frame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months ]
  7. immune cell number ratio,in blood. [ Time Frame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months ]
  8. stress hormone,in blood. [ Time Frame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months ]
    Estradiol(Female),testosterone(male)etc,in bood.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age:18-70
  • male and female
  • signed the informed consent form.
  • Diagnosis:Gastrointestinal cancer diagnosed by imaging,cell and pathology report.
  • Eastern Cooperative oncology Group(ECOG)O-2,life expectancy more than 3 months.
  • Indication for Chemotherapy,no contraindication.
  • First time chemotherapy or at least 6 months after last chemotherapy and radiotherapy.
  • At least 8 weeks after last biotherapy.
  • Surgery:had not received transplantation surgery,at least 2 weeks after last major surgery.

Exclusion Criteria:

  • Chemotherapy is contraindicated.
  • Have the primary disease can cause the neuropathy.
  • A history of other malignant tumor in recent 5 years.
  • Less than 6 months after last chemotherapy or radiotherapy.
  • Less than 8 weeks after last biotherapy.
  • Cinobufotalin allergy.
  • Had received transplantation surgery,less than 2 weeks after last major surgery.
  • Other researchers think is not suitable for this clinical trail.

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): NCT02860429


Contacts
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Contact: Xiaonan Cui, MD,PhD +8618098876725 cxn23@sina.com
Contact: Rui Zhang +8613898872185 zzzrrr1234@sina.com

Locations
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China, Liaoning
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116000
Contact: Xiaonan Cui    +8618098876725    cxn23@sina.com   
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110000
Contact: Rui Zhang    +8613898872185    zzzrrr1234@sina.com   
Sponsors and Collaborators
Xiaonan Cui
Investigators
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Principal Investigator: Xiaonan Cui, MD,PhD The First Affiliated Hospital of Dalian Medical University
Principal Investigator: Rui Zhang Liaoning cancer province
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Responsible Party: Xiaonan Cui, Professor,Chief Physician, The First Affiliated Hospital of Dalian Medical University
ClinicalTrials.gov Identifier: NCT02860429    
Other Study ID Numbers: LCKY2016-37
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases