Status:
TERMINATED
Phase 1/2 Study Evaluating Safety and Potential Efficacy of Allocetra-OTS Via Pressurized Intra-Peritoneal Aerosol Chemotherapy as Add-on to Standard of Care Chemotherapy for Treatment of Peritoneal Metastasis
Lead Sponsor:
Enlivex Therapeutics RDO Ltd.
Conditions:
Peritoneal Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label study to evaluate safety and potential efficacy of Allocetra-OTS in the treatment of patients with peritoneal metastasis as an add-on to the standard of care (SoC) chemotherapy.
Detailed Description
Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) is utilized in patients with malignant dissemination to the peritoneal cavity, for the treatment of peritoneal metastasis that have a high tum...
Eligibility Criteria
Inclusion
- 18 years of age or older.
- Diagnosis of peritoneal metastasis due to any primary tumor by histopathology or cytology
- Possession of unresectable tumors (not eligible for Cytoreductive Surgery / Hyperthermic Intra-Peritoneal Chemoperfusion CRS/HIPEC).
- Adequate performance status and surgical risk
- Adequate hematopoietic, hepatic and renal function
Exclusion
- Extraperitoneal disease.
- Bowel obstruction
- History of Liver cirrhosis with CHILD PUGH classification of B or C or signs of portal hypertension, portal vein thrombosis.
- Patient with known New York Heart Association (NYHA) class 3 or 4 symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias.
- Previous history of organ allograft or stem cell transplantation.
Key Trial Info
Start Date :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05431907
Start Date
June 29 2022
End Date
March 14 2024
Last Update
April 17 2024
Active Locations (1)
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1
The Chaim Sheba Medical Center
Ramat Gan, Israel