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

NCT02860429 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-08-09

No results posted yet for this study

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

Interventions

DRUG

Cinobufacini injection

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

DRUG

chemotherapy

Chemotherapy is the oxaliplatin combination with fluorouracil regimen.

Sponsors & Collaborators

  • Xiaonan Cui

    lead OTHER

Principal Investigators

  • Xiaonan Cui, MD,PhD · The First Affiliated Hospital of Dalian Medical University

  • Rui Zhang · Liaoning cancer province

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02860429 on ClinicalTrials.gov