Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Neoplasm Metastasis

Carcinoma

Peritoneal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Abdominal Neoplasms

Peritoneal Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Cisplatin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Each patient will be scheduled for 3 courses of combined treatment: in total 3 PIPAC with cisplatin 10.5 mg/m2 and doxorubicin 2.1 mg/m2 and 6 cycles of FOLFOX systemic chemotherapy.

Each course of combined treatment will start with PIPAC (a pressurized aerosol containing cisplatin 10.5 mg/m2 and doxorubicin 2.1 mg/m2 diluted in NaCl 0.9% applied through the nebulizer inside the abdominal cavity during laparoscopy). Fourteen days afterward 2 cycles of systemic FOLFOX chemotherapy will be applied within 28 days. The interval between combined treatment courses will be 14 days.

Combined Doxorubicin and Cisplatin Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic FOLFOX chemotherapy

Martynas Lukšta, MD

Augustinas Bausys, MD

Augustinas Bausys, PhD

Martynas Luksta

Skaiste Tulyte, MD

Kestutis Strupas, Prof. MD

Peritoneum is among the most common sites of metastases in gastric cancer. Systemic chemotherapy is the current standard for peritoneal carcinomatosis (PC), although, the treatment results remain extremely poor. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a modern treatment modality for PC, that 1) optimize the drug distribution by applying an aerosol rather than a liquid solution; and 2) apply increased intraperitoneal hydrostatic pressure to increase drug penetration to the target. Despite some encouraging preliminary results for PIPAC efficacy, it is still an investigational treatment. Furthermore, only very limited data exist for bidirectional treatment, which includes a combination of systemic chemotherapy and PIPAC. Thus, this study will investigate the feasibility of PIPAC and systemic chemotherapy combination for gastric cancer patients with peritoneal metastases.

This open-label, single-arm feasibility study will be conducted at two major gastrointestinal cancer treatment centers in Lithuania and will include 37 participants. Gastric cancer patients diagnosed with a synchronous or metachronous peritoneal carcinomatosis based on a clinical, radiological, cytological, and histological examination will be considered for enrollment. Thirty-seven patients willing to participate and meeting the enrollment criteria will be scheduled for the experimental treatment. Three cycles of 1st line palliative systemic chemotherapy will be administered every 28 days and PIPAC with cisplatin 10,5 mg/m2 and doxorubicin 2,1 mg/m2 will be utilized 14 days after each of the systemic chemotherapy cycles. After the 3rd PIPAC procedure patients will be re-assessed and discussed at multidisciplinary team meetings. In case of downstaging patients will be considered for radical gastrectomy±cytoreductive surgery; others for further systemic therapy. All patients will be followed up for 24 months.

PIPAC and FOLFOX for Gastric Cancer Peritoneal Cancer

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) and Systemic Chemotherapy as a First-line Treatment for Gastric Cancer Peritoneal Metastases: Open-label, Single-arm, Multi-center Feasibility Study

Objective tumor response according to RECIST v 1.1 in CT scan performed 1 week after second PIPAC procedure

Objective tumor response according to RECIST v 1.1 in CT scan performed 1 week after third PIPAC procedure

Proportion of patients able to receive all anticipated treatment (3 PIPACs and 6 cycles of FOLFOX)

The number of patients with postoperative complications, defined and graded according to Clavien-Dindo classification

A pathologist blinded to clinical outcomes will evaluate histological tumor response using the Peritoneal Regression Grading Score (PRGS): 1-Complete regression without cancer cells; 2-higher response with prevalence of regressive phenomena and only a few residual cancer cells - PRGS; 3-minor response with prevalence of residual cancer cells and poor regressive phenomena; 4-no response to therapy without regressive phenomena.

A patient will be considered a responder if any reduction in the PRGS during subsequent biopsies will be recorded.

The volume of ascites recorded at every PIPAC procedure.

Ca19-9, carcinoembryonic antigen (CEA), Ca72-4 plasma levels measured at different time points.

Quality of life by EORTC questionnaires measured at different time points.

Time from start of the treatment to death

Time from start of the treatment to progression of the disease

The number of patients with toxicity according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 during the study period

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PIPAC and FOLFOX for Gastric Cancer Peritoneal Cancer	NCT05644249	Gastric Cancer Peritoneal Carc...	Combined Doxoru...	18 Years -	Vilnius University
PIPAC and FOLFOX for Gastric Cancer Peritoneal Cancer	NCT05644249	Gastric Cancer Peritoneal Carc...	Combined Doxoru...	18 Years -	Vilnius University

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