Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin and Doxorubicin in Patients With Gastric Cancer and Peritoneal Carcinomatosis: an Open-label, Single-arm, Phase II Clinical Trial
Objectives: To evaluate the safety and efficacy in terms of the clinical benefit rate (CBR)
of PIPAC in peritoneal carcinomatosis (PC) from gastric cancer (GC) Study design: Single
center, open label, non-randomized, single-arm, repeated single dose study to explore the
efficacy, safety, and CBR of doxorubicin and cisplatin when given as a pressurized
intraperitoneal aerosol chemotherapy (PIPAC) to patients with advanced gastric cancer and
Target subject population:Patients with GC and PC with disease progression after at least
one line of previous i.v. chemotherapy.
Investigational product, dosage and mode of administration Doxorubicin 1.5 mg/m2 body
surface in 50 ml NaCl 0,9% and Cisplatin 7.5 mg/m2 in 50 ml NaCl 0,9% q 4-6 weeks, applied
intraperitoneally as PIPAC.
Duration of treatment: 3 single doses in 6 weeks intervals, duration of treatment is 18
1.1 Primary outcome variable • Clinical Benefit Rate (CBR) according to Response Evaluation
Criteria In Solid Tumors (RECIST) criteria (version 1.1) after 3 cycles of PIPAC with
cisplatin and doxorubicin.
1.2 Secondary outcome variables
- The observed survival (OS)
- The median time to progression (TTP) according to RECIST criteria after three cycles of
PIPAC with cisplatin and doxorubicin
- The Peritoneal Carcinomatosis Index (PCI) before and after therapy
- The degree of histological regression assessed by pathological review
- Apoptosis as assessed by immunohistochemical analysis
- The difference in ascites volume before and after the first, second, and third PIPAC
application 1.3 Patient reported outcomes (PROs)
- European Organization for Research and Treatment of Cancer (EORTC) quality of life
questionnaire (QLQ-C30, German version ) 1.4 Safety
- Safety and tolerability will be assessed by collection of adverse events, according to
the Common Terminology Criteria for Adverse Events (CTCAE) including physical
examination results, laboratory assessments (chemistry and hematology).
1.5 Biological monitoring
• Basic research investigating expression of genes associated with drug resistance.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical Benefit Rate
Clinical Benefit Rate according to RECIST criteria after 3 cycles of PIPAC with cisplatin and doxorubicin.
within 3 months after treatment completion
Marc A Reymond, MD
Ruhr University of Bochum
Germany: Federal Institute for Drugs and Medical Devices