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Using PAXG chemotherapy for pancreatic cancer treatment

PAXG Out in the Country

Phase 4 Interventional IRCCS San Raffaele · NCT04480268

This study is testing if a new combination of chemotherapy drugs can help people with advanced pancreatic cancer feel better and improve their treatment outcomes.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment175 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorIRCCS San Raffaele Academic / other
Drugs / interventionschemotherapy
Locations30 sites (Aviano and 29 other locations)
Trial IDNCT04480268 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the PAXG chemotherapy regimen (cisplatin, nab-paclitaxel, capecitabine, and gemcitabine) as a first-line treatment for patients with pancreatic ductal adenocarcinoma (PDAC) that is borderline resectable, locally advanced, or metastatic. The research aims to assess how well this regimen can be reproduced in everyday clinical settings outside of large volume centers. Patients will be treated according to specific inclusion and exclusion criteria, and data will be collected from multiple participating institutions over a defined period.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with a diagnosis of pancreatic adenocarcinoma that is locally advanced or metastatic and who have a good performance status.

Not a fit: Patients with early-stage pancreatic cancer or those with poor performance status may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve survival rates for patients with advanced pancreatic cancer by validating an effective chemotherapy regimen.

How similar studies have performed: Previous studies have shown promising results with the PAXG regimen, indicating its potential effectiveness in treating advanced pancreatic cancer.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* cyto/histological diagnosis of pancreatic adenocarcinoma;
* locally advanced and metastatic disease corresponding to clinical stage III-IV according to TNM 8th Ed. 2017 and borderline resectable disease as anatomically defined according to NCCN Guidelines Version 1.2020 - Pancreatic Adenocarcinoma and biologically defined according to the International consensus on definition and criteria of borderline resectable pancreatic ductal adenocarcinoma 2017 (CA 19.9 \> 500 IU/ml);
* ECOG Performance Status ≤1;
* adequate bone marrow function (GB ≥ 3500/mm3, neutrophils ≥1500/mm3, platelets ≥ 100000/mm3, Hb ≥10 g/dl), kidney function (serum creatinine \< 1.5 mg/dL) and liver function (ALT and AST \< 3 ULN and Serum total bilirubin ≤ 1.5 ULN);
* Patient of child-bearing potential must agree to use two medically acceptable methods of contraception (one for the patient and one for the partner) during the study and for 4 months after the last study treatment intake for women and 6 months for men;
* patients must have received at least 1 cycle (28 days) of the PAXG treatment for the disease within the timeframe starting from January 1 2020 to December 31st 2020 ;
* patient information and signed written informed consent.

Exclusion Criteria:

* previous chemotherapy treatment for recurrent disease;
* concurrent treatment with experimental drugs;
* presence of symptomatic brain metastases;
* heart failure, arrhythmia and/or acute myocardial infarction within 6 months prior to the beginning of PAXG treatment;
* women on pregnancy or lactation;
* history of interstitial lung disease;
* history of connective tissue diseases (systemic lupus erythematosus, systemic sclerosis, etc. ).

Where this trial is running

Aviano and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pancreatic Ductal AdenocarcinomaCombination chemotherapyPAXG
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.