Clinical trial · Interventional
Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine Chemotherapy for Pancreatic Cancer 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Neoplasm | Pancreatic Neoplasm | ALIAS | 0.90 |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interventional
- description
- Eligible patients affected by pancreatic cancer PM will be enrolled according to in-/exclusion criteria. Each patient will be scheduled for three treatment combined courses for a total of six cycles of endovenous Nabpaclitaxel-Gemcitabine chemotherapy and three of Nabpaclitaxel-PIPAC.
- interventionNames
- Drug: Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine
Primary outcomes (1)
- measure
- Disease Control Rate (DCR)
- timeFrame
- Three and a half years
- description
- The Disease Control Rate (DCR) defined as the combined incidence of complete response (CR), partial response (PR) and stable disease (SD) according to the RECIST v. 1.1 criteria during study treatments and the EOT visit.
Secondary outcomes (9)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (1)
- DERIVEDDi Giorgio A, Ferracci F, Bagala C, Carbone C, Salvatore L, Strippoli A, Attalla El Halabieh M, Abatini C, Alfieri S, Pacelli F, Tortora G. Combined Nabpaclitaxel pressurized intraPeritoneal aerosol chemotherapy with systemic Nabpaclitaxel-Gemcitabine chemotherapy for pancreatic cancer peritoneal metastases: protocol of single-arm, open-label, phase II trial (Nab-PIPAC trial). Pleura Peritoneum. 2024 Nov 6;9(3):121-129. doi: 10.1515/pp-2024-0010. eCollection 2024 Sep. PMID 39544430