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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cinobufacini injection | Experimental | 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. |
|
| Control group | Other | Only receive the same chemotherapy with the experimental groups.No Cinobufacini injection.And have the same adjuvant treatment with the experimental groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cinobufacini injection | Drug | cinobufacini injection 20ml mixed with 5% Glucose injection 500ml started at the first day of chemotherapy until seven days once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| neural electrophysiological test | every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),up to 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaonan Cui, MD,PhD | Contact | +8618098876725 | cxn23@sina.com | |
| Rui Zhang | Contact | +8613898872185 | zzzrrr1234@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaonan Cui, MD,PhD | The First Affiliated Hospital of Dalian Medical University | Principal Investigator |
| Rui Zhang | Liaoning cancer province | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | 116000 | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 26, 2019 | |
| Reset | Apr 25, 2019 | |
| Release | Jul 23, 2020 | |
| Reset | Aug 5, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 26, 2019 | Apr 25, 2019 | |||
| Jul 23, 2020 |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C545813 | huachansu |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| chemotherapy | Drug | Chemotherapy is the oxaliplatin combination with fluorouracil regimen. |
|
| 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 |
| Liaoning Cancer Hospital | Shenyang | Liaoning | 110000 | China |
|
| Aug 5, 2020 |
| D005767 |
| Gastrointestinal Diseases |