Combined chemotherapy for pancreatic cancer with peritoneal metastases

Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine Chemotherapy for Pancreatic Cancer Peritoneal Metastases - A Single-arm, Open-label, Phase II Trial: Nab-PIPAC Trial

This study is testing a new combination of chemotherapy treatments for people with pancreatic cancer that has spread to the abdominal area to see if it can help them live longer and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Academic / other)
• Drugs / interventions: chemotherapy, doxorubicin
• Locations: 1 site (Rome)
• Trial ID: NCT05371223 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a combined chemotherapy approach using Nabpaclitaxel delivered via Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) alongside systemic Nabpaclitaxel-Gemcitabine for patients with pancreatic cancer that has spread to the peritoneum. The trial aims to assess not only the antitumoral activity but also the safety, feasibility, overall survival, progression-free survival, quality of life, and pharmacokinetics of the treatment. Additionally, it will monitor patients' nutritional status and the molecular changes in the disease over time. This innovative approach seeks to provide a new curative option for a condition with limited treatment success.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed pancreatic cancer and peritoneal carcinomatosis.

Not a fit: Patients with advanced systemic disease or extraabdominal tumor spread may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with pancreatic cancer peritoneal metastases.

How similar studies have performed: Previous studies have shown promising results with similar approaches, particularly with the use of PIPAC for other chemotherapeutic agents.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years;
* Willing and able to provide written and informed consent;
* Histological or cytological proof of pancreatic cancer;
* Metastatic disease with peritoneal carcinomatosis determined by the treating physician, based on abdominal CT or MR and/or diagnostic laparotomy or laparoscopy;
* Evaluable disease defined by RECIST 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
* Life expectancy of at least 3 months;
* No contraindication for laparoscopy;
* No contraindication for drugs used in the study;
* Adequate bone marrow function: Absolute neutrophil count ≥ 1500 cell./mm3; Platelets ≥ 100000 cell./mm3;
* Hemoglobin ≥ 9 g/dl
* Adequate renal function (serum creatinine up to 1.5 times the maximal limit of the local laboratory) or else based upon clinical evaluation;

Exclusion Criteria:

* Advanced metastatic systemic disease with clinical deterioration;
* Patients with extraabdominal tumor spread;
* Patients with a germline or somatic pathogenic variant involving an (Homologous Recombination Repair) HRR-related gene;
* Symptoms of gastrointestinal occlusion and total parenteral nutritional support;
* Patients defined as "refractory" to previous systemic treatment with Nab-paclitaxel and Gemcitabine administered for locally advanced pancreatic cancer (patients treated with Nabpaclitaxel-Gemcitabine for a locally advanced disease may be included if PM developed after at least 6 months from the end of previous chemotherapy);
* History of severe and unexpected reactions to Nabpaclitaxel or Gemcitabine derivates
* Known hypersensitivity reaction to drugs chemically related to Nabpaclitaxel, Gemcitabine and their excipients;
* Severe cardiac disease (recent myocardial ischemia, severe cardiac arrhythmias, severe cardiac failure);
* Clinical disease progression after first 2 months of systemic Nabpaclitaxel Gemcitabine chemotherapy;
* Any concurrent severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk of associated with study participation or investigational product administration or may interfere with compliance with study procedures or the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into the study;

Where this trial is running

Rome

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy (Recruiting)

Study contacts

• Principal investigator: Andrea Di Giorgio, MD — UOS trattamenti integrati della carcinosi peritoneale avanzata -UOC Chirurgia del peritoneo e retroperitoneo - Fondazione Policlinico Universitario A. Gemelli IRCCS
• Study coordinator: Andrea Di Giorgio, MD

Conditions Peritoneal Carcinomatosis; Pancreas Neoplasm