Back to resultsA Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC) (NALPAC)
Primary Purpose
Metastatic Pancreatic Ductal Adenocarcinoma
Status
Recruiting
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Nanoliposomal irinotecan
5 FU
Leucovorin
Oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Ductal Adenocarcinoma
Eligibility Criteria
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
Sites / Locations
- AZ St-Lucas
- UZ Antwerpen
- AZ ImeldaRecruiting
- ULB Erasme
- Cliniques Universitaires Saint-Luc UCL
- Grand Hopital de Charleroi
- AZ Maria Middelares
- University Hospital Ghent
- CHC MontLégia
- AZ Sint-Maarten
- CHU Ambroise Paré
- CHR Namur
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm A NALIRI
Arm B NALIRINOX
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Efficacy of NALIRINOX and NALIRI through Progression-Free Survival at D85
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 Outcome Measures
Safety/toxicity and tolerability profil: Severety of adverse events
Adverse events and Serious Adverse events will be assessed during the study treatment and until 14 days later. Severety will be graded according to the NCI-CTCAE version 5.0 and relationship to the study medication will be defined.
Safety/toxicity and tolerability profil: Laboratory assessments
Standard laboratory safety assessments: They are mandatory prior to each administration of study medication and at the 15 days follow-up visit.
Clinically significant vs not clinically significant.
Safety/toxicity and tolerability profil: ECOG
WHO ECOG performance status (PS) will be defined prior to each administration of study medication and at the 15 days follow-up visit following the ECOG Performance Status Scale.
Safety/toxicity and tolerability profil: review of body systems
A full review of body systems will be performed: heart rate, blood pressure, respiratory rate, body temperature, height, weight and ECG (screening visit only, unless clinically indicated).
Clinically significant versus not clinically significant
Progression Free Survival and sensitivity analysis: Effect of Center on prognostic factors
The effect of potential prognostic factors will be assessed through sensitivity analyses, including:
Investigational Center
Progression Free Survival and sensitivity analysis: Effect of tumor location on prognostic factors
The effect of potential prognostic factors will be assessed through sensitivity analyses, including:
Location of tumor (head of the pancreas versus other location)
Progression Free Survival and sensitivity analysis: Effect of previous chemotherapy on prognostic factors
The effect of potential prognostic factors will be assessed through sensitivity analyses, including:
Previous chemotherapy: gemcitabine alone vs gem-abx
Progression Free Survival and sensitivity analysis: effect of ECOG on prognostic factors
The effect of potential prognostic factors will be assessed through sensitivity analyses, including:
WHO ECOG performance status (0 versus 1)
Objective tumor response: Rate of complete response and partial response
Tumor (response) evaluation will be performed according to RECIST criteria v. 1.1 (CT scan thorax, abdomen and pelvis or MRI abdomen and pelvis + CT chest) based upon the investigator's assessment. Overall response is defined as a best response of either CR or PR (CR+PR).
Duration of overall survival
For patients who are still alive at the time of study analysis or who are lost to follow up, survival will be censored at the last recorded date that the patient is known to be alive or at the date of data cut-off, whatever occurs earlier.
Duration of disease control
Disease control is defined as a best response of either CR, PR, or SD (CR+PR+SD).
Duration of response
The duration of response will be censored on the date of last known tumor assessment for not progressed patients lost to follow up or deceased prior to the next planned tumor assessment (within 60 days). Not evaluable patients at one time point assessment will be censored at the date of last known assessment.
Full Information
NCT ID
NCT05472259
First Posted
December 9, 2021
Last Updated
July 25, 2022
Sponsor
Belgian Group of Digestive Oncology
Collaborators
University Hospital St Luc, Brussels
1. Study Identification
Unique Protocol Identification Number
NCT05472259
Brief Title
A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Belgian Group of Digestive Oncology
Collaborators
University Hospital St Luc, Brussels
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Ductal Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A NALIRI
Arm Type
Active Comparator
Arm Description
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 Title
Arm B NALIRINOX
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nanoliposomal irinotecan
Other Intervention Name(s)
Onyvide
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
5 FU
Other Intervention Name(s)
Fluorouracil
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
Folinate, Elvorine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Only administered in the investigational arm (Nalirinox): a dose of 60 mg/m² is administered in combination with nanoliposomal irinotecan, 5FU and Leucovorin
Primary Outcome Measure Information:
Title
Efficacy of NALIRINOX and NALIRI through Progression-Free Survival at D85
Description
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.
Time Frame
at day 85 from randomization
Secondary Outcome Measure Information:
Title
Safety/toxicity and tolerability profil: Severety of adverse events
Description
Adverse events and Serious Adverse events will be assessed during the study treatment and until 14 days later. Severety will be graded according to the NCI-CTCAE version 5.0 and relationship to the study medication will be defined.
Time Frame
until 14 days after End of Treatment
Title
Safety/toxicity and tolerability profil: Laboratory assessments
Description
Standard laboratory safety assessments: They are mandatory prior to each administration of study medication and at the 15 days follow-up visit.
Clinically significant vs not clinically significant.
Time Frame
until 14 days after End of Treatment
Title
Safety/toxicity and tolerability profil: ECOG
Description
WHO ECOG performance status (PS) will be defined prior to each administration of study medication and at the 15 days follow-up visit following the ECOG Performance Status Scale.
Time Frame
until 14 days after End of Treatment
Title
Safety/toxicity and tolerability profil: review of body systems
Description
A full review of body systems will be performed: heart rate, blood pressure, respiratory rate, body temperature, height, weight and ECG (screening visit only, unless clinically indicated).
Clinically significant versus not clinically significant
Time Frame
until 14 days after End of Treatment
Title
Progression Free Survival and sensitivity analysis: Effect of Center on prognostic factors
Description
The effect of potential prognostic factors will be assessed through sensitivity analyses, including:
Investigational Center
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.
Title
Progression Free Survival and sensitivity analysis: Effect of tumor location on prognostic factors
Description
The effect of potential prognostic factors will be assessed through sensitivity analyses, including:
Location of tumor (head of the pancreas versus other location)
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
Title
Progression Free Survival and sensitivity analysis: Effect of previous chemotherapy on prognostic factors
Description
The effect of potential prognostic factors will be assessed through sensitivity analyses, including:
Previous chemotherapy: gemcitabine alone vs gem-abx
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
Title
Progression Free Survival and sensitivity analysis: effect of ECOG on prognostic factors
Description
The effect of potential prognostic factors will be assessed through sensitivity analyses, including:
WHO ECOG performance status (0 versus 1)
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
Title
Objective tumor response: Rate of complete response and partial response
Description
Tumor (response) evaluation will be performed according to RECIST criteria v. 1.1 (CT scan thorax, abdomen and pelvis or MRI abdomen and pelvis + CT chest) based upon the investigator's assessment. Overall response is defined as a best response of either CR or PR (CR+PR).
Time Frame
performed within 28 days before start therapy, 3 times every 6 weeks and afterwards every 8 weeks
Title
Duration of overall survival
Description
For patients who are still alive at the time of study analysis or who are lost to follow up, survival will be censored at the last recorded date that the patient is known to be alive or at the date of data cut-off, whatever occurs earlier.
Time Frame
Time from Day 1 of therapy to death until maximum 5 years after End of Treatment
Title
Duration of disease control
Description
Disease control is defined as a best response of either CR, PR, or SD (CR+PR+SD).
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
Title
Duration of response
Description
The duration of response will be censored on the date of last known tumor assessment for not progressed patients lost to follow up or deceased prior to the next planned tumor assessment (within 60 days). Not evaluable patients at one time point assessment will be censored at the date of last known assessment.
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
Other Pre-specified Outcome Measures:
Title
Exploratory lab investigation for potential prognostic and predictive biomarkers on blood and tumor samples
Description
Translational research will be performed for potential prognostic and predictive biomarkers. For that purpose, plasma samples will be kept in the selected centres' biobanks.
The translational research will be carried out on tumor samples collected before the start of treatment and on blood samples collected as per below.
Tumor tissue:
10 slices of the paraffin embedded tissue collected during the diagnosis of the disease will be collected.
Blood samples:
Two 10 ml blood samples from each patient who consents to participate in the biological study will be collected before the start of the treatment, and before each cycle till the discontinuation of the treatment.
The exact measurements that will be done, have not been defined yet.
Time Frame
Sapmples will be collected throughout the study and shipped to the sponsor maximum 1 year after last 15 day follow-up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lina Dewever
Phone
+32 (0) 479 36 63 82
Email
lina.dewever@bgdo.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ine De Bruyne
Phone
+32 (0) 478 81 04 27
Email
i.debruyne@bgdo.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Borbath
Organizational Affiliation
University hospital St-luc, Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ St-Lucas
City
Brugge
State/Province
West-Vlaanderen
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tania Maerten
First Name & Middle Initial & Last Name & Degree
Liesbeth Holvoet, Dr
Facility Name
UZ Antwerpen
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanne Wouters
First Name & Middle Initial & Last Name & Degree
Timon Vandamme, Prof
Facility Name
AZ Imelda
City
Bonheiden
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doreen Iwens
First Name & Middle Initial & Last Name & Degree
Pieter-Jan Cuyle, Dr.
Facility Name
ULB Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Axelle Ghilain
First Name & Middle Initial & Last Name & Degree
Jean-Luc Van Laethem, Dr
Facility Name
Cliniques Universitaires Saint-Luc UCL
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuan Le
First Name & Middle Initial & Last Name & Degree
Ivan Borbath, Prof
Facility Name
Grand Hopital de Charleroi
City
Charleroi
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Papier
First Name & Middle Initial & Last Name & Degree
Javier Carrasco, Dr.
Facility Name
AZ Maria Middelares
City
Ghent
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaux Vansteelant
First Name & Middle Initial & Last Name & Degree
Els Monsaert, Dr.
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tine Derre
First Name & Middle Initial & Last Name & Degree
Karen Geboes, Prof.
Facility Name
CHC MontLégia
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jocelyne Gilson
First Name & Middle Initial & Last Name & Degree
Ghislain Houbiers, Dr
Facility Name
AZ Sint-Maarten
City
Mechelen
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrien Beullens
First Name & Middle Initial & Last Name & Degree
Leen Mortier, Dr.
Facility Name
CHU Ambroise Paré
City
Mons
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariane Blockmans
First Name & Middle Initial & Last Name & Degree
Marie Diaz, Dr.
Facility Name
CHR Namur
City
Namur
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Leon
First Name & Middle Initial & Last Name & Degree
Yeter Gokburun, Dr.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)
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