---
title: A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)
nct_id: NCT05472259
overall_status: RECRUITING
phase: PHASE2
sponsor: Belgian Group of Digestive Oncology
study_type: INTERVENTIONAL
primary_condition: Metastatic Pancreatic Ductal Adenocarcinoma
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05472259.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05472259"
ct_last_update_post_date: 2025-02-06
last_seen_at: "2026-05-12T06:58:26.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)

**Official Title:** A Non-comparative Randomized Phase 2 Study, Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), Progressive After Gemcitabine-Abraxane or Gemcitabine Monotherapy

**NCT ID:** [NCT05472259](https://clinicaltrials.gov/study/NCT05472259)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 134
- **Lead Sponsor:** Belgian Group of Digestive Oncology
- **Collaborators:** University Hospital St Luc, Brussels
- **Conditions:** Metastatic Pancreatic Ductal Adenocarcinoma
- **Start Date:** 2022-05-25
- **Completion Date:** 2027-12-31
- **CT.gov Last Update:** 2025-02-06

## Brief Summary

A non-comparative randomized phase 2 study, evaluating the efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for metastatic pancreatic ductal adenocarcinoma (PDAC), progressive after Gemcitabine-Abraxane or Gemcitabine monotherapy

## Detailed Description

Based on the results of previous studies, the sponsor aims to assess efficacy and safety of this triplet (irinotecan, 5FU/LV and oxaliplatin) in second-line treatment in fit patients (ECOG 0-1) metastatic PDAC.

The primary objective is to assess the efficacy of NALIRINOX (= investigational arm) and NALIRI (= standard care arm) in terms of Progression-Free Survival Rate (PFSR).

As secondary objectives, the following will be evaluated in both arms:

* Safety/toxicity and tolerability profile according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.
* Progression free survival (PFS)
* Overall response rate and duration of response as assessed by imaging (RECIST 1.1) and tumor markers
* Overall survival (OS)

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Arm A NALIRI** (ACTIVE_COMPARATOR) — Cycle length: 14 days

Day 1:

* Leucovorin: 400 mg/m² IV - Dilute in 250 mL DSW and administer over two hours
* Liposomal irinotecan (FBE): 70 mg/m² IV\* - Dilute in 500 mL DSW and administer over 90 min
* 5 FU: 2400 mg/m² IV - Dilute in 500 to 1000 mL 0,9% NS of DSW and administer as a continuous IV infusion over 46 hours. To accommodate an ambulatory pump for outpatient treatment can be administered undiluted (50 mg/mL) or the total dose diluted in 100 to 150 mL NS.

  * Patients who are known to be homozygous for UGT1A1\*28 should start treatment with 50 mg/m2 ONIVYDE. If they do not encounter drug related toxicities during the first cycle of therapy (started at a reduced dose of 50 mg/m2), they may have the dose of ONIVYDE increased to a dose of 70 mg/m2 in subsequent cycles based on individual patient tolerance.
- **Arm B NALIRINOX** (EXPERIMENTAL) — Cycle length: 14 days

Day 1:

* Oxaliplatin 60 mg IV - Dilute in 500 mL D5W and administer over two hours (prior to leucovorin). Shorter oxaliplatin administration schedules (eg. 1mg/m2 per minute) appear to be safe.
* Leucovorin: 400 mg/m² IV - Dilute in 250 mL DSW and administer over two hours (after oxaliplatin)
* Nanoliposomal irinotecan (FBE): 50 mg/m² IV - Dilute in 500 mL D5W and administer over 90 min
* 5 FU: 2400 mg/m² IV - Dilute in 500 to 1000 mL 0,9% NS of DSW and administer as a continuous IV infusion over 46 hours. To accommodate an ambulatory pump for outpatient treatment can be administered undiluted (50 mg/mL) or the total dose diluted in 100 to 150 mL NS.

## Interventions

- **Nanoliposomal irinotecan** (DRUG) — In the control arm (Naliri) a dose of 70mg/m² is administered in combination with 5FU and leucovorin In the investigational arm (Nalirinox) a dose of 50mg/m² is administered in combination with 5FU, leucovorin and oxaliplatin
- **5 FU** (DRUG) — In the control arm (Naliri) a dose of 2400 mg/m² is administered in combination with nanoliposomal irinotecan and leucovorin In the investigational arm (Nalirinox) a dose of 2400 mg/m² is administered in combination with nanoliposomal irinotecan, leucovorin and oxaliplatin
- **Leucovorin** (DRUG) — In the control arm (Naliri) a dose of 400 mg/m² is administered in combination with nanoliposomal irinotecan and 5FU In the investigational arm (Nalirinox) a dose of 400 mg/m² is administered in combination with nanoliposomal irinotecan, 5FU and oxaliplatin
- **Oxaliplatin** (DRUG) — Only administered in the investigational arm (Nalirinox): a dose of 60 mg/m² is administered in combination with nanoliposomal irinotecan, 5FU and Leucovorin

## Primary Outcomes

- **Efficacy of NALIRINOX and NALIRI through Progression-Free Survival at D85** _(time frame: at day 85 from randomization)_ — NALIRINOX is the investigational arm and NALIRI is the standard care arm. The efficacy will be assessed in terms of the Progression-Free Survival Rate (PFSR). This is defined as the proportion of patients alive and free of progression at day 85.

## Secondary Outcomes

- **Safety/toxicity and tolerability profil: Severety of adverse events** _(time frame: until 14 days after End of Treatment)_
- **Safety/toxicity and tolerability profil: Laboratory assessments** _(time frame: until 14 days after End of Treatment)_
- **Safety/toxicity and tolerability profil: ECOG** _(time frame: until 14 days after End of Treatment)_
- **Safety/toxicity and tolerability profil: review of body systems** _(time frame: until 14 days after End of Treatment)_
- **Progression Free Survival and sensitivity analysis: Effect of Center on prognostic factors** _(time frame: From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment.)_
- **Progression Free Survival and sensitivity analysis: Effect of tumor location on prognostic factors** _(time frame: From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment)_
- **Progression Free Survival and sensitivity analysis: Effect of previous chemotherapy on prognostic factors** _(time frame: From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment)_
- **Progression Free Survival and sensitivity analysis: effect of ECOG on prognostic factors** _(time frame: From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment)_
- **Objective tumor response: Rate of complete response and partial response** _(time frame: performed within 28 days before start therapy, 3 times every 6 weeks and afterwards every 8 weeks)_
- **Duration of overall survival** _(time frame: Time from Day 1 of therapy to death until maximum 5 years after End of Treatment)_
- **Duration of disease control** _(time frame: From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment)_
- **Duration of response** _(time frame: Time from measurement criteria are first met for CR/PR to either the first time disease progression is documented or death (for not progressed patients who deceased within 60 days from last tumor assessment) until maximum 5 years after EOT)_

## Locations (13)

- 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 St-Lucas, Bruges, West-Vlaanderen, Belgium — _NOT_YET_RECRUITING_
- AZ Imelda, Bonheiden, Belgium — _RECRUITING_
- Grand Hopital de Charleroi, Charleroi, Belgium — _RECRUITING_
- AZ Maria Middelares, Ghent, Belgium — _RECRUITING_
- University Hospital Ghent, Ghent, Belgium — _RECRUITING_
- Pôle Hospitalier Jolimont (HELORA), Haine-Saint-Paul, Belgium — _RECRUITING_
- CHU Ambroise Paré, Mons, Belgium — _RECRUITING_
- CHR Namur, Namur, Belgium — _RECRUITING_
- AZ Turnhout, Turnhout, Belgium — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.uz antwerpen|antwerp|antwerp|belgium` — added _(2026-05-12)_
- `locations.ulb erasme|brussels|brussels capital|belgium` — added _(2026-05-12)_
- `locations.cliniques universitaires saint-luc ucl|brussels|brussels capital|belgium` — added _(2026-05-12)_
- `locations.chc montlégia|liège|liège|belgium` — added _(2026-05-12)_
- `locations.az st-lucas|bruges|west-vlaanderen|belgium` — added _(2026-05-12)_
- `locations.az imelda|bonheiden||belgium` — added _(2026-05-12)_
- `locations.grand hopital de charleroi|charleroi||belgium` — added _(2026-05-12)_
- `locations.az maria middelares|ghent||belgium` — added _(2026-05-12)_
- `locations.university hospital ghent|ghent||belgium` — added _(2026-05-12)_
- `locations.pôle hospitalier jolimont (helora)|haine-saint-paul||belgium` — added _(2026-05-12)_
- `locations.chu ambroise paré|mons||belgium` — added _(2026-05-12)_
- `locations.chr namur|namur||belgium` — added _(2026-05-12)_
- `locations.az turnhout|turnhout||belgium` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05472259.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05472259*  
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