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

NCT ID: NCT02530398

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-06-30

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cinobufacini group

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.

Group Type: EXPERIMENTAL

Cinobufacini Injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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 Ⅲ-Ⅳ;

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dongfang Hospital Beijing University of Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Quanwang Li

Chief of oncology dept

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oncology dept; Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Quanwang Li, master

Role: CONTACT

quanwangli@126.com

86-010-67689787

Facility Contacts

Quanwang Li, master

Role: primary

quanwangli@126.com

86-010-67689787

Jinglin Ye, master

Role: backup

284504641@qq.com

86-15210828680

Other Identifiers

2013-XTCX-05

Identifier Type: -

Identifier Source: org_study_id