Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine Chemotherapy for Pancreatic Cancer Peritoneal Metastases

• Status: Not yet recruiting
• Trial end date: 2025-07-30
• Target enrollment: 0
• Participant gender: All

Summary

Combined chemotherapy consisting of endovenous Nabpaclitaxel-Gemcitabine and Nabpaclitaxel-PIPAC may be a promising treatment for patients affected by pancreatic cancer PM who are in need of curative options.

The purpose of this study is to evaluate the antitumoral activity of combined Nabpaclitaxel-PIPAC and systemic Nabpaclitaxel-Gemcitabine chemotherapy for pancreatic cancer peritoneal metastases.

Secondary objectives include the evaluation of the feasibility, the safety, further assessment of the antitumoral activity, the overall and progression free survival, the QoL, the pharmacokinetics of Nabpaclitaxel PIPAC.

Furthermore, the study aims to evaluate the patients' nutritional status and the molecular evolution of PM along treatment with a time-course translational research.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine

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 extrabdominal 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;