Gastrointestinal NeoplasmsPhase 4NCT02860429
Clinical Trial of Cinobufacini Injection Combined With Oxaliplatin Regimen on Gastrointestine Carcinoma
A Phase 4 study testing Cinobufacini injection and chemotherapy in people with Gastrointestinal Neoplasms, run by Xiaonan Cui at 2 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Neoplasms
- What is being tested?
- Cinobufacini injection and chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2016to Sep 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
China2 sites
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116000
Xiaonan Cui, +8618098876725, cxn23@sina.com
Liaoning Cancer Hospital
Shenyang, Liaoning, 110000
Rui Zhang, +8613898872185, zzzrrr1234@sina.com
About this study
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
- Being tested
- Cinobufacini injection, chemotherapy
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinobufacini injectionDrug
cinobufacini injection 20ml mixed with 5% Glucose injection 500ml started at the first day of chemotherapy until seven days once a day.
chemotherapyDrug
Chemotherapy is the oxaliplatin combination with fluorouracil regimen.
| Study group | Role | What they receive |
|---|---|---|
| Cinobufacini injection | Experimental | 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. Receives: Drug: Cinobufacini injection; Drug: chemotherapy |
| Control group | Other | Only receive the same chemotherapy with the experimental groups.No Cinobufacini injection.And have the same adjuvant treatment with the experimental groups. Receives: Drug: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
neural electrophysiological test
Measured: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),up to 6 months
Secondary outcomes (8)
The quality of life questionnaire(QLQ)-C30
Measured: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
National Cancer Institute(NCI)Common Toxicity Criteria
Measured: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
Levi sensory nerve toxicity classification standard
Measured: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
image test
Measured: For adjuvant chemotherapy patients every 3 months.For saving chemotherapy patients every 2 months.anticipate up to 1 years.
inflammatory cytokines,in blood.
For example:Interleukin(IL)-6,tumor necrosis factor(TNF)etc,in bood
Measured: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
peroxidase reaction,in blood.
Measured: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
immune cell number ratio,in blood.
Measured: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
stress hormone,in blood.
Estradiol(Female),testosterone(male)etc,in bood.
Measured: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaonan Cui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaonan Cui, The First Affiliated Hospital of Dalian Medical University
- Investigators
- Xiaonan Cui, MD,PhD, Principal investigator, The First Affiliated Hospital of Dalian Medical UniversityRui Zhang, Principal investigator, Liaoning cancer province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860429
- Sponsor's protocol ID
- LCKY2016-37
- Status last verified
- Aug 2016
- First submitted
- 1 Aug 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Cinobufacini Injection Combined With Oxaliplatin Regimen on Gastrointestine Carcinoma
- ClinicalTrials.gov ID
- NCT02860429
- Acronym / sponsor ID
- LCKY2016-37
- Conditions
- Gastrointestinal Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xiaonan CuiUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinobufacini injection | Experimental | Drug: Cinobufacini injection, Drug: chemotherapyCapsule 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. |
| Control group | Other | Drug: chemotherapyOnly receive the same chemotherapy with the experimental groups.No Cinobufacini injection.And have the same adjuvant treatment with the experimental groups. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cinobufacini injectioncinobufacini injection 20ml mixed with 5% Glucose injection 500ml started at the first day of chemotherapy until seven days once a day. | Drug | Cinobufacini injection |
| chemotherapyChemotherapy is the oxaliplatin combination with fluorouracil regimen. | Drug | Cinobufacini injection, Control group |
Primary outcome
neural electrophysiological test
Time frame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),up to 6 months
8 secondary outcomes
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
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
Levi sensory nerve toxicity classification standard
Time frame: 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.
inflammatory cytokines,in blood.
Time frame: 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
immune cell number ratio,in blood.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaonan Cui, MD,PhD principal investigator
The First Affiliated Hospital of Dalian Medical University
Rui Zhang principal investigator
Liaoning cancer province
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cinobufacini injection and chemotherapy in people with Gastrointestinal Neoplasms, run by Xiaonan Cui at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaonan Cui, MD,PhD (+8618098876725, cxn23@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neural electrophysiological test (time frame: every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2016.