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

NCT ID: NCT02860429

Last Updated: 2016-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30

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.

Conditions

Gastrointestinal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cinobufacini injection

Intervention Type: DRUG

cinobufacini injection 20ml mixed with 5% Glucose injection 500ml started at the first day of chemotherapy until seven days once a day.

chemotherapy

Intervention Type: DRUG

Chemotherapy is the oxaliplatin combination with fluorouracil regimen.

Control group

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

Group Type: OTHER

chemotherapy

Intervention Type: DRUG

Chemotherapy is the oxaliplatin combination with fluorouracil regimen.

Interventions

Cinobufacini injection

cinobufacini injection 20ml mixed with 5% Glucose injection 500ml started at the first day of chemotherapy until seven days once a day.

Intervention Type: DRUG

chemotherapy

Chemotherapy is the oxaliplatin combination with fluorouracil regimen.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiaonan Cui

OTHER

Sponsor Role: lead

Responsible Party

Xiaonan Cui

Professor,Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiaonan Cui, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Dalian Medical University

Rui Zhang

Role: PRINCIPAL_INVESTIGATOR

Liaoning cancer province

Locations

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Countries

China

Central Contacts

Xiaonan Cui, MD,PhD

Role: CONTACT

cxn23@sina.com

+8618098876725

Rui Zhang

Role: CONTACT

zzzrrr1234@sina.com

+8613898872185

Facility Contacts

Xiaonan Cui

Role: primary

cxn23@sina.com

+8618098876725

Rui Zhang

Role: primary

zzzrrr1234@sina.com

+8613898872185

Other Identifiers

LCKY2016-37

Identifier Type: -

Identifier Source: org_study_id