Evaluating new treatment combinations for metastatic pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 clinical trial aims to evaluate the efficacy and safety of two treatment combinations, 5-FU + NALIRI and 5-FU + NALIRINOX, in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed after previous therapies. The study will assess the primary outcome of progression-free survival rate, along with secondary outcomes including overall survival and safety profiles. Eligible participants must have measurable disease and meet specific health criteria, ensuring they are fit for treatment. The trial is designed to provide insights into the effectiveness of these combinations in a challenging cancer type.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically proven metastatic adenocarcinoma of the pancreas
* Progression documented after gemcitabine-Abraxane, or gemcitabine monotherapy
* Signed written informed consent
* Age ≥ 18
* ECOG PS 0/1 at study entry
* Measurable disease
* Adequate renal (serum creatinine ≤ 1.5x upper reference range), liver (total bilirubin ≤ 1.5x upper reference range) and hematopoietic functions (PMN ≥ 1,5x109/L, platelets ≥ 100x109/L, hemoglobin ≥ 9g/dl)
* INR/PTT ≤ 1.5x ULN
* Life expectancy of at least 12 weeks
* Effective contraception for both male and female patients if the risk of conception exists during treatment and for one month after the last administration
* Peripheral Neuropathy \< grade 2

Exclusion Criteria:

* Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension
* History of myocardial infarction, deep venous or arterial thrombosis, CVA during the last 6 months
* Known hypersensitivity to any of the components, including excipients, of study treatments
* Previous malignancy in the last past 3 years except basal cell cancer of the skin or preinvasive cancer of the cervix or carcinoma in situ of any type
* Pregnancy or breast feeding
* Medical or psychological conditions that would not permit the patient to complete the study or sign inform consent
* Unstable angina, congestive heart failure ≥NYHA class II
* Uncontrolled hypertension despite optimal management (systolic blood pressure \>150 mmHg or diastolic pressure \> 90mmHg)
* HIV infection
* Complete DPD deficiency
* Liver failure, cirrhosis Child Pugh B or C
* Active chronic hepatitis B or C with a need for antiviral treatment
* Brain metastasis
* Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of treatment
* History of organ allograft
* Ongoing uncontrolled, serious infection
* Renal failure requiring dialysis
* Patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study

Where it's running

• UZ Antwerpen
  Antwerp, Antwerp, Belgium Recruiting
• ULB Erasme
  Brussels, Brussels Capital, Belgium Recruiting
• Cliniques Universitaires Saint-Luc UCL
  Brussels, Brussels Capital, Belgium Recruiting
• CHC MontLégia
  Liège, Liège, Belgium Recruiting
• AZ Imelda
  Bonheiden, Belgium Recruiting
• Grand Hopital de Charleroi
  Charleroi, Belgium Recruiting

Study contacts

• Principal investigator: Ivan Borbath — University hospital St-luc, Brussel
• Study coordinator: Lina Dewever
• Email: lina.dewever@bgdo.org
• Phone: +32 (0) 479 36 63 82

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Pegcetacoplan with modified FOLFIRINOX for metastatic pancreatic cancer

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  Recruiting at 2 sites Phase 3 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Hefei, Anhui and 70 other locations · NCT07165951

• Using ctDNA to guide earlier switching from first-line mFOLFIRINOX in metastatic pancreatic cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.