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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiaonan Cui
• Treatments: Bufanolides; Oxaliplatin

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.