NCT02530398

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

2.8 years

First QC Date

August 19, 2015

Last Update Submit

August 29, 2017

Conditions

Digestive System CancerMalignant Ascites

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Drug: Cinobufacini Injection

Interventions

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.

cinobufacini group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, Beijing Municipality, 100078, China

RECRUITING

MeSH Terms

Conditions

Digestive System Neoplasms

Interventions

huachansu

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsDigestive System Diseases

Central Study Contacts

Quanwang Li, master

CONTACT

86-010-67689787quanwangli@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of oncology dept

Study Record Dates

First Submitted

August 19, 2015

First Posted

August 21, 2015

Study Start

July 1, 2015

Primary Completion

April 1, 2018

Study Completion

June 1, 2018

Last Updated

August 30, 2017

Record last verified: 2017-08

Locations

CN(1)