A Tolerance Trial of Cinobufacini Injection Intraperitoneal Perfusion on Digestive System Cancer With Ascites

Malignant Ascites Clinical Trial

Official title:

Single-arm, Non-randomized, Open, Drug Tolerance Trial of Cinobufacini Injection Intraperitoneal Perfusion Treatment on Digestive System Cancer Patients With Ascites

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02530398
• Other study ID #: 2013-XTCX-05
• Status: Recruiting
• Phase: Phase 1
• First received: August 19, 2015
• Last updated: August 29, 2017
• Start date: July 2015
• Est. completion date: June 2018

Study information

• Verified date: August 2017
• Source: Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
• Contact: Quanwang Li, master
• Phone: 86-010-67689787
• Email: quanwangli[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. digestive system cancer with malignant ascites;

2. the age of 18-80 years;

3. neither systemic chemotherapy, nor peritoneal perfusion therapy in 2 weeks;

4. no cinobufotalin preparations in 2 weeks;

5. ECOG score 0-3;

6. the amount of ascites is above level II (1000-3000ml);

7. volunteer to participate and sign informed consent.

Exclusion Criteria:

1. non-cancer causes of ascites, such as peritonitis, cirrhosis,hypoalbuminemia;

2. Had an allergy history to toad's skin or its products or had adverse reactions like arrhythmia when applied before;

3. B ultrasound or CT confirmed the peritoneal cavity is separated which will affect the treatment of ascites and the estimation of ascites;

4. The conditions admit and the patients would better to undergo chemotherapy of malignant ascites;

5. cardiac function is ?-?;

6. ALT> 3 times upper limit and / or TBIL> 2 times upper limit;

7. renal function is phase 3 and above 3;

8. have severe neutropenia of degree II or above, and / or moderate or severe anemia, and / or thrombocytopenia of degree II or above;

9. Consolidated mental disorders.

Related Conditions & MeSH terms

• Ascites
• Digestive System Cancer
• Digestive System Neoplasms
• Malignant Ascites

Intervention

Drug:
• Cinobufacini Injection
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.

Locations

Country	Name	City	State
China	Oncology dept; Dongfang Hospital Affiliated to Beijing University of Chinese Medicine	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 days