Digestive System CancerPhase 1NCT02530398
A Tolerance Trial of Cinobufacini Injection Intraperitoneal Perfusion on Digestive System Cancer With Ascites
A Phase 1 study testing Cinobufacini Injection in people with Digestive System Cancer and Malignant Ascites, run by Dongfang Hospital Beijing University of Chinese Medicine at 1 site in China.
Trial summary
To evaluate the tolerance and safety of cinobufacini injection intraperitoneal treatment on digestive system cancer patients with malignant ascites, and propose dosage regimens for future clinical trials. The clinical trial is divided into two parts, including single and successive administration. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Digestive System Cancer, Malignant Ascites
- What is being tested?
- Cinobufacini Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Jun 2018
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- digestive system cancer with malignant ascites;
- the age of 18-80 years;
- neither systemic chemotherapy, nor peritoneal perfusion therapy in 2 weeks;
- no cinobufotalin preparations in 2 weeks;
- ECOG score 0-3;
- the amount of ascites is above level II (1000-3000ml);
- volunteer to participate and sign informed consent.
Who cannot join
- non-cancer causes of ascites, such as peritonitis, cirrhosis，hypoalbuminemia;
- Had an allergy history to toad's skin or its products or had adverse reactions like arrhythmia when applied before;
- B ultrasound or CT confirmed the peritoneal cavity is separated which will affect the treatment of ascites and the estimation of ascites;
- The conditions admit and the patients would better to undergo chemotherapy of malignant ascites;
- cardiac function is Ⅲ-Ⅳ;
- ALT> 3 times upper limit and / or TBIL> 2 times upper limit;
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- renal function is phase 3 and above 3;
- have severe neutropenia of degree II or above, and / or moderate or severe anemia, and / or thrombocytopenia of degree II or above;
- Consolidated mental disorders.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Oncology dept; Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100078
Quanwang Li, master, 86-010-67689787, quanwangli@126.com
Jinglin Ye, master, 86-15210828680, 284504641@qq.com
About this study
Official title: Single-arm, Non-randomized, Open, Drug Tolerance Trial of Cinobufacini Injection Intraperitoneal Perfusion Treatment on Digestive System Cancer Patients With Ascites
To evaluate the tolerance and safety of cinobufacini injection intraperitoneal treatment on digestive system cancer patients with malignant ascites, and propose dosage regimens for future clinical trials. The clinical trial is divided into two parts, including single and successive administration.
Read the detailed description
To evaluate the tolerance and safety of cinobufacini injection intraperitoneal treatment on digestive system cancer patients with malignant ascites, and propose dosage regimens for future clinical trials. A single-arm, non-randomized, open, drug tolerance trial will be conducted. The clinical trial is divided into two parts, including single and successive administration.The single administration includes 7 groups, dose is escalated from 15ml to 180ml, with 2-6 patients per dose level. Central venous catheters will be preserved for drainage of ascites, after the drainage of most of ascites, we will slowly inject a dilute concentration of cinobufacini injection with escalated dosage through the catheters. This treatment will be given only once, and the volunteers will be observed for 24 hours. Then we will evaluate the observation indexes, including adverse events, vital signs, electrocardiogram, blood routine, urine routine, hepatic and renal function, etc. The successive administration includes 2 groups, according to the result of single administration, choose the second largest tolerance dose to conduct the 1st group of successive administration. If there are significant adverse effects, then drop to a lower dose to conduct the 2nd group; if the trial shows no adverse effects, it upgrades to a higher dose (the maximum tolerated dose) to conduct the 2nd group. The treatment will be given 3 times a week, 2 weeks as a period. Adverse effects will be evaluated during and after treatment.
- Conditions
- Digestive System Cancer, Malignant Ascites
- Being tested
- Cinobufacini Injection
- Medical subject headings
- Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinobufacini InjectionDrug
Cinobufacini injection is extracted from a traditional Chinese medicine Bufo toad skins, it's something cold and poisonous with damp evil. On one hand it can kill the cancer cells direct; on the other hand it has the ability to contract blood vessels and inhibit the formation of tumor new vessels. It has been widely used in the treatment of various malignancies.
| Study group | Role | What they receive |
|---|---|---|
| cinobufacini group | Experimental | 48 patients(half males and half females) will be in the group.Central venous catheters will be preserved for drainage of ascites, after the drainage of most of ascites, we will slowly inject a dilute concentration of cinobufacini injection with escalated dosage through the catheters. Then we will evaluate the observation indexes, including adverse events, vital signs, electrocardiogram, blood routine, urine routine, hepatic and renal function, etc. Receives: Drug: Cinobufacini Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the grade of adverse events
According to The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 4.0)，grade the severity of adverse events (AE) that occur with drug treatment，which include symptoms, electrocardiogram, blood routine, urine routine, hepatic and renal function. Each item is graded 1-5.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quanwang Li, Dongfang Hospital Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530398
- Sponsor's protocol ID
- 2013-XTCX-05
- Status last verified
- Aug 2017
- First submitted
- 19 Aug 2015
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Non-randomized, Open, Drug Tolerance Trial of Cinobufacini Injection Intraperitoneal Perfusion Treatment on Digestive System Cancer Patients With Ascites
- ClinicalTrials.gov ID
- NCT02530398
- Acronym / sponsor ID
- 2013-XTCX-05
- Conditions
- Digestive System Cancer, Malignant Ascites
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 21 Aug 2015 (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.
To evaluate the tolerance and safety of cinobufacini injection intraperitoneal treatment on digestive system cancer patients with malignant ascites, and propose dosage regimens for future clinical trials. The clinical trial is divided into two parts, including single and successive administration.
Detailed description
To evaluate the tolerance and safety of cinobufacini injection intraperitoneal treatment on digestive system cancer patients with malignant ascites, and propose dosage regimens for future clinical trials. A single-arm, non-randomized, open, drug tolerance trial will be conducted. The clinical trial is divided into two parts, including single and successive administration.The single administration includes 7 groups, dose is escalated from 15ml to 180ml, with 2-6 patients per dose level. Central venous catheters will be preserved for drainage of ascites, after the drainage of most of ascites, we will slowly inject a dilute concentration of cinobufacini injection with escalated dosage through the catheters. This treatment will be given only once, and the volunteers will be observed for 24 hours. Then we will evaluate the observation indexes, including adverse events, vital signs, electrocardiogram, blood routine, urine routine, hepatic and renal function, etc. The successive administration includes 2 groups, according to the result of single administration, choose the second largest tolerance dose to conduct the 1st group of successive administration. If there are significant adverse effects, then drop to a lower dose to conduct the 2nd group; if the trial shows no adverse effects, it upgrades to a higher dose (the maximum tolerated dose) to conduct the 2nd group. The treatment will be given 3 times a week, 2 weeks as a period. Adverse effects will be evaluated during and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cinobufacini group | Experimental | Drug: Cinobufacini Injection48 patients(half males and half females) will be in the group.Central venous catheters will be preserved for drainage of ascites, after the drainage of most of ascites, we will slowly inject a dilute concentration of cinobufacini injection with escalated dosage through the catheters. Then we will evaluate the observation indexes, including adverse events, vital signs, electrocardiogram, blood routine, urine routine, hepatic and renal function, etc. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- digestive system cancer with malignant ascites;
- the age of 18-80 years;
- neither systemic chemotherapy, nor peritoneal perfusion therapy in 2 weeks;
- no cinobufotalin preparations in 2 weeks;
- ECOG score 0-3;
Key exclusion criteria (9 listed)
- non-cancer causes of ascites, such as peritonitis, cirrhosis，hypoalbuminemia;
- Had an allergy history to toad's skin or its products or had adverse reactions like arrhythmia when applied before;
- B ultrasound or CT confirmed the peritoneal cavity is separated which will affect the treatment of ascites and the estimation of ascites;
- The conditions admit and the patients would better to undergo chemotherapy of malignant ascites;
- cardiac function is Ⅲ-Ⅳ;
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 is extracted from a traditional Chinese medicine Bufo toad skins, it's something cold and poisonous with damp evil. On one hand it can kill the cancer cells direct; on the other hand it has the ability to contract blood vessels and inhibit the formation of tumor new vessels. It has been widely used in the treatment of various malignancies. | Drug | cinobufacini group |
Primary outcome
the grade of adverse events
Time frame: 14 days
According to The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 4.0)，grade the severity of adverse events (AE) that occur with drug treatment，which include symptoms, electrocardiogram, blood routine, urine routine, hepatic and renal function. Each item is graded 1-5.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cinobufacini Injection in people with Digestive System Cancer and Malignant Ascites, run by Dongfang Hospital Beijing University of Chinese Medicine at 1 site 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 7 inclusion and 9 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 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Quanwang Li, master (86-010-67689787, quanwangli@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the grade of adverse events (time frame: 14 days). 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 30 Aug 2017.