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

X

Xiaonan Cui

Status and phase

Unknown
Phase 4

Conditions

Gastrointestinal Neoplasms

Treatments

Drug: chemotherapy
Drug: Cinobufacini injection

Study type

Interventional

Funder types

Other

Identifiers

NCT02860429
LCKY2016-37

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Cinobufacini injection
Experimental group
Description:
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.
Treatment:
Drug: Cinobufacini injection
Drug: chemotherapy
Control group
Other group
Description:
Only receive the same chemotherapy with the experimental groups.No Cinobufacini injection.And have the same adjuvant treatment with the experimental groups.
Treatment:
Drug: chemotherapy

Trial contacts and locations

2

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Central trial contact

Rui Zhang; Xiaonan Cui, MD,PhD

Data sourced from clinicaltrials.gov

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