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

Gastrointestinal Neoplasms Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02860429
• Other study ID #: LCKY2016-37
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 1, 2016
• Last updated: August 8, 2016
• Start date: September 2016

Study information

• Verified date: August 2016
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: Xiaonan Cui, MD,PhD
• Phone: +8618098876725
• Email: cxn23[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms

Intervention

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.
• chemotherapy
Chemotherapy is the oxaliplatin combination with fluorouracil regimen.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	Liaoning Cancer Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Xiaonan Cui

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neural electrophysiological test		every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),up to 6 months	No
Secondary	The quality of life questionnaire(QLQ)-C30		every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months	No
Secondary	National Cancer Institute(NCI)Common Toxicity Criteria		every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months	No
Secondary	Levi sensory nerve toxicity classification standard		every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months	No
Secondary	image test		For adjuvant chemotherapy patients every 3 months.For saving chemotherapy patients every 2 months.anticipate up to 1 years.	No
Secondary	inflammatory cytokines,in blood.	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	No
Secondary	peroxidase reaction,in blood.		every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months	No
Secondary	immune cell number ratio,in blood.		every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months	No
Secondary	stress hormone,in blood.	Estradiol(Female),testosterone(male)etc,in bood.	every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months	No