Clinical trial · Interventional
A Tolerance Trial of Cinobufacini Injection Intraperitoneal Perfusion on Digestive System Cancer With Ascites
Single-arm, Non-randomized, Open, Drug Tolerance Trial of Cinobufacini Injection Intraperitoneal Perfusion Treatment on Digestive System Cancer Patients With Ascites
NCT02530398CI-TRIAL-00029357unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digestive System Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Malignant Ascites | Digestive System Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cinobufacini Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cinobufacini group
- description
- 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.
- interventionNames
- Drug: Cinobufacini Injection
Primary outcomes (1)
- measure
- the grade of adverse events
- timeFrame
- 14 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.