Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine Chemotherapy for Pancreatic Cancer Peritoneal Metastases
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · May 7, 2022
Trial Information
Current as of July 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment approach for patients with pancreatic cancer that has spread to the lining of the abdomen, known as peritoneal metastases. The treatment combines two types of chemotherapy: one delivered through the bloodstream (Nabpaclitaxel-Gemcitabine) and another delivered directly into the abdominal cavity using a special aerosol method (Nabpaclitaxel-PIPAC). The goal is to see how effective this combined therapy is in fighting the cancer and to assess its safety and impact on patients' quality of life.
To participate in this trial, patients need to be at least 18 years old and have a confirmed diagnosis of pancreatic cancer with peritoneal metastases. They should have a good overall health status to tolerate the treatment and must not have any serious other medical conditions that could complicate their participation. Throughout the trial, participants will receive the treatment and undergo regular evaluations to monitor their health, the effectiveness of the treatment, and how it affects their daily life. This trial is currently recruiting, and it aims to provide promising new options for patients facing this challenging disease.
Gender
ALL
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;
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rome, , Italy
Patients applied
Trial Officials
Andrea Di Giorgio, MD
Principal Investigator
UOS trattamenti integrati della carcinosi peritoneale avanzata -UOC Chirurgia del peritoneo e retroperitoneo - Fondazione Policlinico Universitario A. Gemelli IRCCS
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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