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

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dongfang Hospital Affiliated to Beijing University of Chinese Medicine; Dongfang Hospital Beijing University of Chinese Medicine
• Treatments: Bufanolides

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.