Clinical Trial of Cinobufacini Injection Combined With Oxaliplatin Regimen on Gastrointestine Carcinoma
试验速览
- 阶段
- 4 期
- 发起方
- Xiaonan Cui
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- neural electrophysiological test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Cinobufacini injection (Drug)
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.
干预措施: chemotherapy (Drug)
Control group
Only receive the same chemotherapy with the experimental groups.No Cinobufacini injection.And have the same adjuvant treatment with the experimental groups.
干预措施: chemotherapy (Drug)
结局指标
主要结局
neural electrophysiological test
时间窗: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),up to 6 months
次要结局
- image test(For adjuvant chemotherapy patients every 3 months.For saving chemotherapy patients every 2 months.anticipate up to 1 years.)
- immune cell number ratio,in blood.(every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months)
- inflammatory cytokines,in blood.(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)
- 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)
- stress hormone,in blood.(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)
研究者
Xiaonan Cui
Professor,Chief Physician
The First Affiliated Hospital of Dalian Medical University