Clinical trial NCT02530398: A Tolerance Trial of Cinobufacini Injection Intraperitoneal Perfusion on Digestive System Cancer With Ascites
Official title: Single-arm, Non-randomized, Open, Drug Tolerance Trial of Cinobufacini Injection Intraperitoneal Perfusion Treatment on Digestive System Cancer Patients With Ascites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Digestive System Cancer
Malignant Ascites
Lead sponsor: Dongfang Hospital Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the grade of adverse events
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Oncology dept; Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
state: Beijing
Study officials:
References: