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

Phase 4

• Conditions: Gastrointestinal Neoplasms
• Interventions: Drug: Cinobufacini injection; Drug: chemotherapy

• Registration Number: NCT02860429
• Lead Sponsor: Xiaonan Cui

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-08
• Last Update Submitted: 2016-08-08
• Study First Posted: 2016-08-09
• Last Update Posted: 2016-08-09
• Study Start: 2016-09
• Primary Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cinobufacini injection	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.
Cinobufacini injection	chemotherapy	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	chemotherapy	Only receive the same chemotherapy with the experimental groups.No Cinobufacini injection.And have the same adjuvant treatment with the experimental groups.

Primary Outcome Measures

Name	Time	Method
neural electrophysiological test	every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),up to 6 months

Secondary Outcome Measures

Name	Time	Method
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
peroxidase reaction,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	For example:Interleukin(IL)-6,tumor necrosis factor(TNF)etc,in bood
stress hormone,in blood.	every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months	Estradiol(Female),testosterone(male)etc,in bood.
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

Trial Locations

Locations (2)

The First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China

Liaoning Cancer Hospital; 🇨🇳 Shenyang, Liaoning, China