Pancreatic CancerPhase 2HOLIPANCNCT04617457
Chemotherapy and Surgical Resection in Patients With Hepatic Oligometastatic Adenocarcinoma of the Pancreas
A Phase 2 study testing nal-irinotecan (nal-iri) (Onyvide), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA) in people with Pancreatic Cancer and Metastasis, run by University of Cologne at 11 sites in Germany.
Trial summary
This is an interventional, open-label, non-randomised, multicentre, single-arm phase II clinical trial. Eligible patients with hepatic oligometastatic adenocarcinoma of the pancreas will receive neoadjuvant combination chemotherapy (liposomal irinotecan, oxaliplatin, 5-fluouracil, folinic acid (NAPOX)) in cycles of 14… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Metastasis, Surgery
- What is being tested?
- nal-irinotecan (nal-iri) (Onyvide), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 11 sitesGermany
- Study dates
- 10 Oct 2021to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of treatment-naïve limited hepatic metastatic adenocarcinoma of the pancreas Definition of limited hepatic metastasis: 1 to 5 metastases in CT/MRI and/or contrast-enhanced ultrasound scan, which are potentially resectable or treatable by ablative procedures (Note 1: Patients also fulfil this inclusion criterion if a hepatic metastasis was partly or entirely removed as part of the diagnosis and is thus not detectable by CT/MRI and/or contrast-enhanced ultrasound scan at screening. Note 2: If more than 5 metastases are unexpectedly detected during surgery, it is not a violation of this inclusion criterion if the excess metastases had not been detectable by CT/MRI and/or contrast-enhanced ultrasound scan at screening.)
- Measurable disease according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate renal, hepatic and bone marrow function, defined as
- Calculated creatinine clearance ≥60 mL/min
- Total bilirubin ≤2 mg/dL; patients with biliary stent may be included if bilirubin level decreased to ≤2 mg/dL after stent insertion
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- alanin-aminotransferase and aspartat-aminotransferase (ALT and AST) ≤5 × upper limit of normal (ULN)
- Absolute neutrophil count (ANC) ≥1.5 × 109/L
- Thrombocytes ≥100 × 109/L
- Haemoglobin ≥9 g/dL
- activated partial thromboplastin time (aPTT) ≤1.5 × ULN and Quick value ≥70%
- Patients ≥18 years at the time of signing the informed consent
- Females of childbearing potential (FCBPs) must agree to use highly effective contraceptive measures (Pearl index <1) or practice true abstinence from any heterosexual intercourse for the duration of treatment and for at least 1 month after the last IMP administration (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient). A woman will be considered as being of childbearing potential unless she is at least 50 years old and, moreover, has gone through menopause for at least 2 years or has been surgically sterilised.
- Males must agree to use condoms or practice true abstinence from any heterosexual intercourse for the duration of IMP treatment and at least 6 months after the last IMP administration (true abstinence is acceptable if this is in line with the patient's preferred and usual lifestyle). Male patients must furthermore refrain from donating sperm during the clinical trial until at least 6 months after the last IMP administration.
- Patient's written informed consent prior to any trial-specific procedure
- Patient's legal capacity to consent to participation in the clinical trial
Who cannot join
- Acinar cell carcinoma and/or neuroendocrine carcinoma of the pancreas
- Symptomatic clinically significant ascites
- Evidence of any distant metastases other than limited hepatic metastasis as defined in inclusion criterion 1
- Any tumour-specific pretreatment of the adenocarcinoma of the pancreas (including but not limited to surgery, radiation therapy, chemotherapy or ablative procedures)
- Any malignancies other than adenocarcinoma of the pancreas in the 5 years before the start of the clinical trial except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, breast cancer, prostate cancer or superficial bladder tumours (Ta, Tis and T1)
- Hypersensitivity to any of the IMPs or any of the excipients
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- Any major surgery within 4 weeks before the first IMP administration
- Pregnant or breast-feeding female
- Known chronic inflammatory bowel disease, bowel obstruction or chronic diarrhoea Grade ≥2 according to NCI CTCAE version 5.0
- Peripheral polyneuropathy Grade ≥2 according to NCI CTCAE version 5.0
- Known interstitial lung disease (ILD) or pulmonary fibrosis
- Radiographic evidence of severe portal hypertension
- Liver cirrhosis ≥ Child Pugh B
- Cholestasis or cholangitis despite adequate biliary stenting; treatment with anti-infectious agents is permitted; patient must be disease-free and without anti-infectious treatment for 7 days before the first IMP administration
- Active infection requiring systemic therapy
- Known HIV seropositivity
- Active or chronic Hepatitis B or Hepatitis C infection
- Known glucuronidation deficiency (Gilbert's syndrome) (specific screening not required)
- Known complete dihydropyrimidine dehydrogenase (DPD) deficiency (specific screening according to the recommendations of the Summary of Product Characteristics (SmPC) in effect for 5-FU; patients with a known complete DPD deficiency must be excluded; patients with a known partial DPD deficiency may be included
- Clinically significant cardiovascular or vascular disease or disorder ≤6 months before enrolment into the clinical trial (e.g. myocardial infarction, unstable angina pectoris, chronic heart failure New York Heart Association (NYHA) ≥ Grade 2, uncontrolled arrhythmia, cerebral infarction)
- Pulmonary embolism, deep venous thrombosis or arterial thromboembolism ≤6 months before before the first IMP administration
- Any other severe concomitant disease or disorder, which could influence patient's ability to participate in the clinical trial and his/her safety during the trial or interfere with interpretation of results; e.g., severe hepatic, renal, pulmonary, cardiovascular, metabolic or psychiatric disorders
- Requirement for live vaccination within 4 weeks before the first IMP administration and during neoadjuvant chemotherapy
- Use of strong CYP3A4 inhibitors (Strong CYP3A4 inhibitors have to be discontinued at least one week prior to start of trial treatment.); use of strong UGT1A1 inhibitors or strong CYP3A4 inducers unless there are no therapeutic alternatives
- Treatment with nucleoside analogues such as brivudine within 4 weeks before the first IMP administration or requirement for concomitant antiviral treatment with brivudine or analogues
- Participation in a clinical trial or experimental drug treatment within 4 weeks before the first IMP administration or within a period of 5 half-lives of the substances administered in a clinical trial or during an experimental drug treatment before the first IMP administration, depending on which period is longest, or simultaneous participation in another clinical trial while taking part in this clinical trial
- Continuing abuse of alcohol, drugs or medical drugs
- Patient committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
- Patients possibly dependent from the investigator including the spouse, children and close relatives of any investigator at the discretion of the investigator)
Trial locations and contacts
11 sites in 1 country.
Dirk Waldschmidt, MD contact
11 sites in 1 country
Germany11 sites, 7 recruiting
- Recruiting
University Aachen
Aachen
Georg Wiltberger, MD
Georg Wiltberger, MD
- Active, not recruiting
University of Berlin, Charité, Campus Benjamin-Franklin
Berlin
- Active, not recruiting
University of Bonn
Bonn
- Recruiting
Städtisches Klinikum Dresden
Dresden
Torge Mees, MD
- Active, not recruiting
University of Düsseldorf
Düsseldorf
- Recruiting
University of Freiburg
Freiburg im Breisgau
Uwe Wittel, MD
Uwe Wittel, MD
- Recruiting
University of Halle (Saale)
Halle
Ulrich Ronellenfitsch, MD
- Recruiting
University of Heidelberg
Heidelberg
Rosa Klotz, MD, rosa.klotz@med.uni-heidelberg.de
- Active, not recruiting
Klinikum Großhadern, LMU München
München
- Recruiting
Klinikum Rechts der Isar Technische Universität München
München
Daniel Reim, MD
Daniel Reim, MD
- Recruiting
University of Regensburg
Regensburg
Jens Werner, MD
About this study
Official title: Open-label, Single Arm Phase II Trial Investigating the Efficacy, Safety and Quality of Life of Neoadjuvant Chemotherapy With Liposomal Irinotecan Combined With Oxaliplatin and 5-Fluorouracil/Folinic Acid Followed by Curative Surgical Resection in Patients With Hepatic Oligometastatic Adenocarcinoma of the Pancreas
This is an interventional, open-label, non-randomised, multicentre, single-arm phase II clinical trial.
Eligible patients with hepatic oligometastatic adenocarcinoma of the pancreas will receive neoadjuvant combination chemotherapy (liposomal irinotecan, oxaliplatin, 5-fluouracil, folinic acid (NAPOX)) in cycles of 14 days. Patients with tumour response or stable disease and a resectable primary tumour after the first 4 cycles will undergo explorative laparotomy and synchronous resection of the tumour and hepatic metastases, if feasible; these patients may receive 4 more cycles of neoadjuvant chemotherapy 2-4 weeks after the explorative laparotomy if the surgeon rated the primary tumour as non-resectable during the explorative laparotomy.
Read the detailed description
This is an interventional, open-label, non-randomised, multicentre, single-arm phase II clinical trial.
Eligible patients with hepatic oligometastatic adenocarcinoma of the pancreas will receive neoadjuvant NAPOX chemotherapy in cycles of 14 days.
In patients with progressive disease during or after the first 4 cycles, neoadjuvant chemotherapy will be permanently discontinued. Patients with tumour response or stable disease after the first 4 cycles according to RECIST v1.1 but a non-resectable primary tumour according to the evaluation of an interdisciplinary tumour board will receive 4 more cycles of neoadjuvant chemotherapy. Patients with tumour response or stable disease and a resectable primary tumour after the first 4 cycles will undergo explorative laparotomy and synchronous resection of the tumour and hepatic metastases, if feasible; these patients may receive 4 more cycles of neoadjuvant chemotherapy 2-4 weeks after the explorative laparotomy if the surgeon rated the primary tumour as non-resectable during the explorative laparotomy.
All patients who receive a total of 8 cycles and who then have tumour response or stable disease according to RECIST v1.1 will undergo exploratory laparotomy surgery and synchronous resection of the tumour and hepatic metastases, if feasible according to the surgeon, 2-6 weeks after the last investigational medicinal product (IMP) treatment.
The primary endpoint of the clinical trial is overall survival of patients with an R0/R1 resection after neoadjuvant chemotherapy.
The IMP treatment will be discontinued if tumour progression or inacceptable toxicity occurs or other termination criteria apply.
Adjuvant treatment will not be part of the trial treatment and may be given at the investigator's discretion in accordance with the Onkopedia guideline for pancreatic cancer.
Tumour, stool and blood samples will be collected before start and during the clinical trial for translational research if the patient gives his/her consent to participating in the translational research programme.
- Conditions
- Pancreatic Cancer, Metastasis, Surgery, Oligometastatic Disease
- Being tested
- nal-irinotecan (nal-iri) (Onyvide), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA)
- Keywords
- pancreatic cancer, NAPOX, chemotherapy
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nal-irinotecan (nal-iri) (Onyvide), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA)Drug
Also called nal-irinotecan (nal-iri), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA)
preoperative chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| NAPOX chemotherapy | Experimental | NAPOX chemotherapy in 14-day cycles with the four IMPs given intravenously in the following order: nal-irinotecan, oxaliplatin, folinic acid and 5-fluouracil. Receives: Drug: nal-irinotecan (nal-iri) (Onyvide), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival after R0/R1 resection (OS-res)
OS for patient after macroscopic tumor resection
Measured: max 24 months follow-up
Secondary outcomes (7)
R0/R1 resection rate after neoadjuvant chemotherapy
Fraction of patients that undergo macroscopically complete tumor resection (No and %)
Measured: direct after operation
Overall survival (OS)
time from study inclusion until death (months)
Measured: max 24 months follow-up
Progression-free survival (PFS) after R0/R1 resection according to RECIST v1.1
time from study inclusion until tumor progress/recurrence (months)
Measured: max 24 months follow-up
Type, frequency and severity of adverse events (AE) with severity (SAE) according to NCI CTCAE version 5.0
Number and fraction of AE/SAEs (No and %)
Measured: direct after IMP administration up to 3 months after completion of study
HR-QoL according to EORTC QLQ-C30
Quality of Life according to the EORTC QLQ-C30 questionaire (scale 0 (poor) - 7 (excellent)
Measured: 90 days after operation
Quality of life (QoL) according to EORTC QLQ-PAN-26
Quality of Life according to the EORTC QLQ-PAN26 questionaire (scale 0 (poor) - 7 (excellent)
Measured: 90 days after operation
QoL-adjusted OS
time from study inclusion until death (months) adjusted to quality of life
Measured: max 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start10 Oct 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Servier
- Responsible party
- Principal investigator, Florian Gebauer, University of Witten/Herdecke
- Investigators
- Florian Gebauer, MD, Principal investigator, University of Witten/HerdeckeDirk Waldschmidt, Study director, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617457
- Sponsor's protocol ID
- Uni-Koeln-4067
- Other IDs
- 2019-002734-37, 20-1544-AMG, 2019
- Acronym
- HOLIPANC
- Status last verified
- Jan 2024
- First submitted
- 29 Oct 2020
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gebauer F, Damanakis AI, Popp F, Quaas A, Kutting F, Lutz K, Held S, Deuss B, Goser T, Waldschmidt D, Bruns C. Study protocol of an open-label, single arm phase II trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with Oxaliplatin and 5-fluorouracil/Folinic acid followed by curative surgical resection in patients with hepatic Oligometastatic adenocarcinoma of the pancreas (HOLIPANC). BMC Cancer. 2021 Nov 18;21(1):1239. doi: 10.1186/s12885-021-08966-3.
PubMed 34794396
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single Arm Phase II Trial Investigating the Efficacy, Safety and Quality of Life of Neoadjuvant Chemotherapy With Liposomal Irinotecan Combined With Oxaliplatin and 5-Fluorouracil/Folinic Acid Followed by Curative Surgical Resection in Patients With Hepatic Oligometastatic Adenocarcinoma of the Pancreas
- ClinicalTrials.gov ID
- NCT04617457
- Acronym / sponsor ID
- HOLIPANC / Uni-Koeln-4067
- Conditions
- Pancreatic Cancer, Metastasis, Surgery, Oligometastatic Disease
- Keywords
- pancreatic cancer, NAPOX, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Servier
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an interventional, open-label, non-randomised, multicentre, single-arm phase II clinical trial.
Eligible patients with hepatic oligometastatic adenocarcinoma of the pancreas will receive neoadjuvant combination chemotherapy (liposomal irinotecan, oxaliplatin, 5-fluouracil, folinic acid (NAPOX)) in cycles of 14 days. Patients with tumour response or stable disease and a resectable primary tumour after the first 4 cycles will undergo explorative laparotomy and synchronous resection of the tumour and hepatic metastases, if feasible; these patients may receive 4 more cycles of neoadjuvant chemotherapy 2-4 weeks after the explorative laparotomy if the surgeon rated the primary tumour as non-resectable during the explorative laparotomy.
Detailed description
This is an interventional, open-label, non-randomised, multicentre, single-arm phase II clinical trial.
Eligible patients with hepatic oligometastatic adenocarcinoma of the pancreas will receive neoadjuvant NAPOX chemotherapy in cycles of 14 days.
In patients with progressive disease during or after the first 4 cycles, neoadjuvant chemotherapy will be permanently discontinued. Patients with tumour response or stable disease after the first 4 cycles according to RECIST v1.1 but a non-resectable primary tumour according to the evaluation of an interdisciplinary tumour board will receive 4 more cycles of neoadjuvant chemotherapy. Patients with tumour response or stable disease and a resectable primary tumour after the first 4 cycles will undergo explorative laparotomy and synchronous resection of the tumour and hepatic metastases, if feasible; these patients may receive 4 more cycles of neoadjuvant chemotherapy 2-4 weeks after the explorative laparotomy if the surgeon rated the primary tumour as non-resectable during the explorative laparotomy.
All patients who receive a total of 8 cycles and who then have tumour response or stable disease according to RECIST v1.1 will undergo exploratory laparotomy surgery and synchronous resection of the tumour and hepatic metastases, if feasible according to the surgeon, 2-6 weeks after the last investigational medicinal product (IMP) treatment.
The primary endpoint of the clinical trial is overall survival of patients with an R0/R1 resection after neoadjuvant chemotherapy.
The IMP treatment will be discontinued if tumour progression or inacceptable toxicity occurs or other termination criteria apply.
Adjuvant treatment will not be part of the trial treatment and may be given at the investigator's discretion in accordance with the Onkopedia guideline for pancreatic cancer.
Tumour, stool and blood samples will be collected before start and during the clinical trial for translational research if the patient gives his/her consent to participating in the translational research programme.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NAPOX chemotherapy | Experimental | Drug: nal-irinotecan (nal-iri) (Onyvide), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA)NAPOX chemotherapy in 14-day cycles with the four IMPs given intravenously in the following order: nal-irinotecan, oxaliplatin, folinic acid and 5-fluouracil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed diagnosis of treatment-naïve limited hepatic metastatic adenocarcinoma of the pancreas Definition of limited hepatic metastasis: 1 to 5 metastases in CT/MRI and/or contrast-enhanced ultrasound scan, which are potentially resectable or treatable by ablative procedures (Note 1: Patients also fulfil this inclusion criterion if a hepatic metastasis was partly or entirely removed as part of the diagnosis and is thus not detectable by CT/MRI and/or contrast-enhanced ultrasound scan at screening. Note 2: If more than 5 metastases are unexpectedly detected during surgery, it is not a violation of this inclusion criterion if the excess metastases had not been detectable by CT/MRI and/or contrast-enhanced ultrasound scan at screening.)
- Measurable disease according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate renal, hepatic and bone marrow function, defined as
- Patients ≥18 years at the time of signing the informed consent
Key exclusion criteria (29 listed)
- Acinar cell carcinoma and/or neuroendocrine carcinoma of the pancreas
- Symptomatic clinically significant ascites
- Evidence of any distant metastases other than limited hepatic metastasis as defined in inclusion criterion 1
- Any tumour-specific pretreatment of the adenocarcinoma of the pancreas (including but not limited to surgery, radiation therapy, chemotherapy or ablative procedures)
- Any malignancies other than adenocarcinoma of the pancreas in the 5 years before the start of the clinical trial except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, breast cancer, prostate cancer or superficial bladder tumours (Ta, Tis and T1)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nal-irinotecan (nal-iri) (Onyvide), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA)Also: nal-irinotecan (nal-iri), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA)preoperative chemotherapy | Drug | NAPOX chemotherapy |
Primary outcome
Overall survival after R0/R1 resection (OS-res)
Time frame: max 24 months follow-up
OS for patient after macroscopic tumor resection
7 secondary outcomes
R0/R1 resection rate after neoadjuvant chemotherapy
Time frame: direct after operation
Overall survival (OS)
Time frame: max 24 months follow-up
Progression-free survival (PFS) after R0/R1 resection according to RECIST v1.1
Time frame: max 24 months follow-up
Type, frequency and severity of adverse events (AE) with severity (SAE) according to NCI CTCAE version 5.0
Time frame: direct after IMP administration up to 3 months after completion of study
HR-QoL according to EORTC QLQ-C30
Time frame: 90 days after operation
Quality of life (QoL) according to EORTC QLQ-PAN-26
Time frame: 90 days after operation
QoL-adjusted OS
Time frame: max 24 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Background: PubMed 34794396Gebauer F, Damanakis AI, Popp F, Quaas A, Kutting F, Lutz K, Held S, Deuss B, Goser T, Waldschmidt D, Bruns C. Study protocol of an open-label, single arm phase II trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with Oxaliplatin and 5-fluorouracil/Folinic acid followed by curative surgical resection in patients with hepatic Oligometastatic adenocarcinoma of the pancreas (HOLIPANC). BMC Cancer. 2021 Nov 18;21(1):1239. doi: 10.1186/s12885-021-08966-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Waldschmidt, MD contact
Florian Gebauer, MD principal investigator
University of Witten/Herdecke
Dirk Waldschmidt study director
University of Cologne
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nal-irinotecan (nal-iri) (Onyvide), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA) in people with Pancreatic Cancer and Metastasis, run by University of Cologne at 11 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florian Gebauer, MD (+492028961563, florian.gebauer@helios-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival after R0/R1 resection (OS-res) (time frame: max 24 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04617457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.