Clinical trial NCT02860429: Clinical Trial of Cinobufacini Injection Combined With Oxaliplatin Regimen on Gastrointestine Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gastrointestinal Neoplasms
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: neural electrophysiological test
timeFrame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),up to 6 months
Secondary outcomes:
measure: The quality of life questionnaire(QLQ)-C30
timeFrame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
measure: National Cancer Institute(NCI)Common Toxicity Criteria
timeFrame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
measure: Levi sensory nerve toxicity classification standard
timeFrame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
measure: image test
timeFrame: For adjuvant chemotherapy patients every 3 months.For saving chemotherapy patients every 2 months.anticipate up to 1 years.
measure: inflammatory cytokines,in blood.
timeFrame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
measure: peroxidase reaction,in blood.
timeFrame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
measure: immune cell number ratio,in blood.
timeFrame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
measure: stress hormone,in blood.
timeFrame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
Other outcomes:
Locations:
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
Study officials:
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Xiaonan Cui, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liaoning cancer province
name: Rui Zhang
role: PRINCIPAL_INVESTIGATOR
References: