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

August 8, 2016 updated by: Xiaonan Cui
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
      • Shenyang, Liaoning, China, 110000
        • Liaoning Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other: Control group
Only receive the same chemotherapy with the experimental groups.No Cinobufacini injection.And have the same adjuvant treatment with the experimental groups.
Drug: chemotherapy
Chemotherapy is the oxaliplatin combination with fluorouracil regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
neural electrophysiological test
Time Frame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),up to 6 months
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The quality of life questionnaire(QLQ)-C30
Time Frame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
National Cancer Institute(NCI)Common Toxicity Criteria
Time Frame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
Levi sensory nerve toxicity classification standard
Time Frame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
image test
Time Frame: For adjuvant chemotherapy patients every 3 months.For saving chemotherapy patients every 2 months.anticipate up to 1 years.
For adjuvant chemotherapy patients every 3 months.For saving chemotherapy patients every 2 months.anticipate up to 1 years.
inflammatory cytokines,in blood.
Time Frame: 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
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
peroxidase reaction,in blood.
Time Frame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
immune cell number ratio,in blood.
Time Frame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
stress hormone,in blood.
Time Frame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
Estradiol(Female),testosterone(male)etc,in bood.
every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaonan Cui

Investigators

  • Principal Investigator: Rui Zhang, Liaoning cancer province

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Estimate)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCKY2016-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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