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

Study Overview
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Brief Summary
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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.

Conditions
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Gastrointestinal Neoplasms

Intervention / Treatment
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* Drug: Cinobufacini injection
* Drug: chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cinobufacini injection<br>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<br>* cinobufacini injection 20ml mixed with 5% Glucose injection 500ml started at the first day of chemotherapy until seven days once a day.<br>Drug: chemotherapy<br>* Chemotherapy is the oxaliplatin combination with fluorouracil regimen.<br>|
| Other: Control group<br>Only receive the same chemotherapy with the experimental groups.No Cinobufacini injection.And have the same adjuvant treatment with the experimental groups. | Drug: chemotherapy<br>* Chemotherapy is the oxaliplatin combination with fluorouracil regimen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neural electrophysiological test |  | every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | For example:Interleukin(IL)-6,tumor necrosis factor(TNF)etc,in bood | every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months | 
| peroxidase reaction,in blood. |  | every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months | 
| immune cell number ratio,in blood. |  | every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months | 
| stress hormone,in blood. | Estradiol(Female),testosterone(male)etc,in bood. | every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months |