Clinical Trial of Cinobufacini Injection Combined With Oxaliplatin Regimen on Gastrointestine Carcinoma
1 other identifier
interventional
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 9, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedAugust 9, 2016
August 1, 2016
1 year
August 1, 2016
August 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
neural electrophysiological test
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),up to 6 months
Secondary Outcomes (8)
The quality of life questionnaire(QLQ)-C30
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
National Cancer Institute(NCI)Common Toxicity Criteria
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
Levi sensory nerve toxicity classification standard
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
image test
For adjuvant chemotherapy patients every 3 months.For saving chemotherapy patients every 2 months.anticipate up to 1 years.
inflammatory cytokines,in blood.
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
- +3 more secondary outcomes
Study Arms (2)
Cinobufacini injection
EXPERIMENTALCapsule 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.
Control group
OTHEROnly receive the same chemotherapy with the experimental groups.No Cinobufacini injection.And have the same adjuvant treatment with the experimental groups.
Interventions
cinobufacini injection 20ml mixed with 5% Glucose injection 500ml started at the first day of chemotherapy until seven days once a day.
Chemotherapy is the oxaliplatin combination with fluorouracil regimen.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiaonan Cuilead
Study Sites (2)
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116000, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaonan Cui, MD,PhD
The First Affiliated Hospital of Dalian Medical University
- PRINCIPAL INVESTIGATOR
Rui Zhang
Liaoning cancer province
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor,Chief Physician
Study Record Dates
First Submitted
August 1, 2016
First Posted
August 9, 2016
Study Start
September 1, 2016
Primary Completion
September 1, 2017
Last Updated
August 9, 2016
Record last verified: 2016-08