Pancreas NeoplasmsNCT06615830
Predictive Value of Transcriptome-based OncoTreat/Oncotarget and Organoid Testing in Metastatic Pancreatic Cancer.
An observational study of Pancreas Neoplasms and Pancreatic Neoplasms, run by Prof. Dr. med. Dres. h.c. Jan Schmidt, MME.
Trial summary
Pancreatic cancer is burdened by a survival of barely 10% at 5 years. About 80% of new cases do not qualify for surgery due to either locally-advanced or metastatic disease. In patients with good performance status (PS), palliative first-line treatments mainly consist of combination regimens, such as FOLFIRINOX… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Neoplasms, Pancreatic Neoplasms, Pancreatic Cancer Metastatic
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All patients with the diagnosis of metastatic adenocarcinoma of the pancreas can be enrolled provided the above mentioned criteria apply. The patients can either be therapy-naive or pretreated.
Who may be able to join
- Informed Consent as documented by signature
- Patients older than 18 years
- Patients with metastatic pancreatic ductal adenocarcinoma
- At least one lesion amenable for surgical excisional biopsy
- ECOG Performance status 0-2
- Radiologically measurable disease
Show all 9Show fewer
- Life expectancy > 3 months
- Absolute leucocyte count >1.5 G/l, platelets >100 G/l
- Serum creatinine <1.5 times of the upper limit of normal or Clearance >50ml/min (according to the CKD-EPI formula)
Who cannot join
- Known allergies or intolerance to one or more compounds present in one of the first line or second line regimens
- Concomitant need for full anticoagulation that cannot be interrupted or bridged prior to tissue biopsy
- ECOG PS >2
- Heart failure (NYHA class III-IV)
- Severe or uncontrolled concurrent illness
- Active viral infection from HIV, HBV or HCV, even if under antiretroviral treatment
- Myocardial infarction within the previous 6 months
- Patients who are pregnant or breastfeeding
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: HIPANC-002 - Observational Performance Study of Transcriptome-Based OncoTreat/OncoTarget Testing With Patient-Derived Organoids in Metastatic Pancreatic Cancer
Pancreatic cancer is burdened by a survival of barely 10% at 5 years. About 80% of new cases do not qualify for surgery due to either locally-advanced or metastatic disease. In patients with good performance status (PS), palliative first-line treatments mainly consist of combination regimens, such as FOLFIRINOX, modified FOLFIRINOX or Gemcitabine-Abraxane. For subjects with a poor PS, instead, guidelines recommend single-agent infusions (e.g. Gemcitabine, Capecitabine or 5-FU alone). Nevertheless, upon disease progression therapeutic options are still scarce and with limited sustained efficacy.
Overall survival in metastatic pancreatic cancer ranges between 9.1 and 13.5 months, while progression-free survival under either FOLFIRINOX or Gemcitabine-Abraxane spans between 5.5 and 6.4 months. This timespan reduces even further when standard second-line regimens must be initiated upon disease progression.
Read more
Nowadays, genomic and transcriptomic analysis are crucial tools in cancer research that enable the identification of genetic mutations and alterations that drive the development and progression of cancer. By studying the changes in the DNA and RNA sequences of cancer cells, researchers can gain insights into the underlying molecular mechanisms of cancer and identify potential therapeutic targets. Genomic analysis can identify specific mutations or alterations that are present in cancer cells, while transcriptomic analysis can reveal changes in gene expression that may be linked to disease progression or response to treatment. These analyses are an essential component for the development of precision medicine approaches, which aim to tailor cancer treatment to the individual genetic profile of each patient.
PDOs can replicate in vitro the biological, genetic and molecular aspects of the primary tumour. Some of their advantages include their rapid growth compared to xenografts, the possibility to perform high-throughput drug screening, and their direct application to precision oncology by predicting best therapies. In this study they will be used as an in vitro comparator of the molecular tests to the clinical course of the patient.
Overall, combining genomic and transcriptomic analysis with PDO technology in cancer research might lead to exponential capacity to provide oncologic patients with extremely tailored and effective cancer treatments in the future.
For HIPANC-002 these tests are being evaluated as non-interventional investigational IVD's. Test results are not to be used for protocol mandated therapy decisions.
Read the detailed description
Primary objective.
The study seeks primarily to demonstrate whether a significant correlation between the IVD based predicted drug sensitivity and the patient's progression-free survival (PFS) in metastatic pancreatic adenocarcinoma after administered standard therapies (which are not chosen based on the test) exist.
Secondary objectives. The study seeks further to
- Explore the correlation between Darwin-test predicted drug sensitivity and patient-derived PDO sensitivity to clinically used drug regimens.
- Explore the correlation between the measured PDO sensitivity to the administered standard therapies and the clinical course of the patient, i.e. PFS (in vivo and in vitro comparison).
- Collect samples for biobanking and future identification of potential new markers associated with tumor response.
Safety objectives.
The study aims to assess:
The rate and severity of 30-days post-operative surgical complications related to laparoscopic surgical biopsy required to retrieve tumoral tissue for IVD-based testing and PDO generation.
The primary outcome is achieved if a significant correlation between IVD based predictions of drug sensitivity and clinically observed patient outcome (progression-free survival after administered standard therapy) exist.
The secondary outcomes are achieved if
- There is a significant correlation between Darwin-test predicted drug sensitivity and patient-derived PDO sensitivity to clinically used drug regimens.
- There is a significant correlation between the measured PDO sensitivity to the administered standard therapies and the clinical course of the patient, i.e. PFS (in vivo and in vitro comparison).
Biobanked samples will be retrospectively analysed to highlight potential biochemical markers of tumour response to therapy if attributable.
The safety outcome will assess descriptively the rate of severe surgical post-operative complication related to laparoscopic surgical biopsy required to retrieve tumoral tissue for IVD-testing and PDO generation and occurring within 30 postoperative days.
Non-Interventional, single arm, observational study
Inclusion criteria:
- Informed Consent as documented by signature
- Patients older than 18 years
- Patients with metastatic pancreatic ductal adenocarcinoma
- At least one lesion amenable for surgical excisional biopsy
- ECOG Performance status 0-2
- Radiologically measurable disease
- Life expectancy > 3 months
- Absolute leucocyte count >1.5 G/l, platelets >100 G/l
- Serum creatinine <1.5 times of the upper limit of normal or Clearance >50ml/min (according to the CKD-EPI formula)
Exclusion criteria:
- Known allergies or intolerance to one or more compounds present in one of the first line or second line regimens
- Concomitant need for full anticoagulation that cannot be interrupted or bridged prior to tissue biopsy
- ECOG PS >2
- Heart failure (NYHA class III-IV)
- Severe or uncontrolled concurrent illness
- Active viral infection from HIV, HBV or HCV, even if under antiretroviral treatment
- Myocardial infarction within the previous 6 months
- Patients who are pregnant or breastfeeding
- Conditions
- Pancreas Neoplasms, Pancreatic Neoplasms, Pancreatic Cancer Metastatic, Pancreatic Adenocarcinoma Metastatic
- Keywords
- Pancreatic cancer, Pancreatic adenocarcinoma, Metastatic pancreatic adenocarcinoma, Organoid, Organoid-driven chemotherapy, Darwin Oncotreat, Darwin Oncotarget, Personalized chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Predictive value of Oncotreat/Oncotarget testing in palliative chemotherapy in pancreatic cancer | The study will include patients with diagnosis of metastatic pancreatic adenocarcinoma. After complete disease staging, patients will undergo laparoscopic surgical biopsy of metastatic tumoral tissue. The tissue will serve for the generation of Oncotreat and Oncotarget tests as well as for patient-derived organoids on which potentially predicted drugs will be benchmarked. Each patient will receive the standard first-line and second-line chemotherapy (chosen among Gemcitabine-Abraxane, or Abraxane-Gemcitabine-FOLFOX or FOLFIRINOX, based on the clinical judgement of the treating oncologist). When progression occurs predictive value of the test with regard to Progression-free Survival (PFS) will be analyzed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is there a significant correlation between Oncotarget/Oncotreat based predicted drug sensitivity and the patient's progression-free survival (PFS) in metastatic pancreatic adenocarcinoma after administered standard therapy ?
To demonstrate a significant correlation between the degree of sensitivity predicted by Oncotreat/Oncotarget to Gemcitabine-Abraxane, or Abraxane-Gemcitabine-FOLFOX (according to the SEQUENCE trial) or FOLFIRINOX (according to the NAPOLI-3 trial), and clinical progression free survival (PFS) in metastatic pancreatic adenocarcinoma.
Measured: From enrollment to disease progression according to the RECIST v1.1 criteria, assessed up to 100 months
Secondary outcomes (1)
1) Correlation between Darwin-test predicted drug sensitivity and patient-derived PDO sensitivity to clinically used drug regimens. 2) Correlation between the measured PDO sensitivity to the administered standard therapies 3) Biobanking
We will analyze if Darwin and PDO prediction are similar or different with regard to the observed chemrsensitivity under a given standard regimen.
We will then also analyze if PDO prediction is reflected in the clinical course of the patient. Tissue and blood samples are stored for Biobanking.
Measured: Observation until progression under given standard treatment using RECIST and TU markers. Follow up until progression and/or death at least 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Jun 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pancreas NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Dres. h.c. Jan Schmidt, MME
- Sponsor type
- University, hospital or other
- Collaborators
- Klinik Hirslanden, Zurich, Insel Gruppe AG, University Hospital Bern, Columbia Research Laboratories
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Dres. h.c. Jan Schmidt, MME, Klinik Hirslanden, Zurich
- Investigators
- Jan Schmidt, Prof. Dr. med. Dres. h.c., MME, Study director, Swiss Surgery/Hirslanden Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615830
- Sponsor's protocol ID
- HIPANC_002
- Status last verified
- Feb 2026
- First submitted
- 1 Sep 2024
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morikawa T, Yoshida M. A useful testing strategy in phase III trials: combined test of superiority and test of equivalence. J Biopharm Stat. 1995 Nov;5(3):297-306. doi: 10.1080/10543409508835115.
PubMed 8580930Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Paluri RK, Kasi A, Young C, Posey JA. Second-line treatment for metastatic pancreatic cancer. Clin Adv Hematol Oncol. 2020 Feb;18(2):106-115.
PubMed 32558804Ettrich TJ, Seufferlein T. Systemic Therapy for Metastatic Pancreatic Cancer. Curr Treat Options Oncol. 2021 Oct 19;22(11):106. doi: 10.1007/s11864-021-00895-4.
PubMed 34665339Zhang XW, Ma YX, Sun Y, Cao YB, Li Q, Xu CA. Gemcitabine in Combination with a Second Cytotoxic Agent in the First-Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer: a Systematic Review and Meta-Analysis. Target Oncol. 2017 Jun;12(3):309-321. doi: 10.1007/s11523-017-0486-5.
PubMed 28353074Nguyen KT, Gamblin TC, Geller DA. World review of laparoscopic liver resection-2,804 patients. Ann Surg. 2009 Nov;250(5):831-41. doi: 10.1097/SLA.0b013e3181b0c4df.
PubMed 19801936Strassburg CP, Manns MP. Approaches to liver biopsy techniques--revisited. Semin Liver Dis. 2006 Nov;26(4):318-27. doi: 10.1055/s-2006-951599.
PubMed 17051446Vasciaveo A, Arriaga JM, de Almeida FN, Zou M, Douglass EF, Picech F, Shibata M, Rodriguez-Calero A, de Brot S, Mitrofanova A, Chua CW, Karan C, Realubit R, Pampou S, Kim JY, Afari SN, Mukhammadov T, Zanella L, Corey E, Alvarez MJ, Rubin MA, Shen MM, Califano A, Abate-Shen C. OncoLoop: A Network-Based Precision Cancer Medicine Framework. Cancer Discov. 2023 Feb 6;13(2):386-409. doi: 10.1158/2159-8290.CD-22-0342.
PubMed 36374194Yang H, Sun L, Liu M, Mao Y. Patient-derived organoids: a promising model for personalized cancer treatment. Gastroenterol Rep (Oxf). 2018 Nov;6(4):243-245. doi: 10.1093/gastro/goy040. Epub 2018 Oct 9. No abstract available.
PubMed 30430011Tiriac H, Bucobo JC, Tzimas D, Grewel S, Lacomb JF, Rowehl LM, Nagula S, Wu M, Kim J, Sasson A, Vignesh S, Martello L, Munoz-Sagastibelza M, Somma J, Tuveson DA, Li E, Buscaglia JM. Successful creation of pancreatic cancer organoids by means of EUS-guided fine-needle biopsy sampling for personalized cancer treatment. Gastrointest Endosc. 2018 Jun;87(6):1474-1480. doi: 10.1016/j.gie.2017.12.032. Epub 2018 Jan 9.
PubMed 29325707Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 2019 Feb;10(1):10-27. doi: 10.14740/wjon1166. Epub 2019 Feb 26.
PubMed 30834048Ilic M, Ilic I. Epidemiology of pancreatic cancer. World J Gastroenterol. 2016 Nov 28;22(44):9694-9705. doi: 10.3748/wjg.v22.i44.9694.
PubMed 27956793Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000 May 24-31;283(20):2701-11. doi: 10.1001/jama.283.20.2701.
PubMed 10819955
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIPANC-002 - Observational Performance Study of Transcriptome-Based OncoTreat/OncoTarget Testing With Patient-Derived Organoids in Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06615830
- Acronym / sponsor ID
- HIPANC_002
- Conditions
- Pancreas Neoplasms, Pancreatic Neoplasms, Pancreatic Cancer Metastatic, Pancreatic Adenocarcinoma Metastatic
- Keywords
- Pancreatic cancer, Pancreatic adenocarcinoma, Metastatic pancreatic adenocarcinoma, Organoid, Organoid-driven chemotherapy, Darwin Oncotreat, Darwin Oncotarget, Personalized chemotherapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Prof. Dr. med. Dres. h.c. Jan Schmidt, MMEUniversity, hospital or other
- Collaborators
- Klinik Hirslanden, Zurich, Insel Gruppe AG, University Hospital Bern, Columbia Research Laboratories
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 27 Sep 2024 (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.
Pancreatic cancer is burdened by a survival of barely 10% at 5 years. About 80% of new cases do not qualify for surgery due to either locally-advanced or metastatic disease. In patients with good performance status (PS), palliative first-line treatments mainly consist of combination regimens, such as FOLFIRINOX, modified FOLFIRINOX or Gemcitabine-Abraxane. For subjects with a poor PS, instead, guidelines recommend single-agent infusions (e.g. Gemcitabine, Capecitabine or 5-FU alone). Nevertheless, upon disease progression therapeutic options are still scarce and with limited sustained efficacy.
Overall survival in metastatic pancreatic cancer ranges between 9.1 and 13.5 months, while progression-free survival under either FOLFIRINOX or Gemcitabine-Abraxane spans between 5.5 and 6.4 months. This timespan reduces even further when standard second-line regimens must be initiated upon disease progression.
Nowadays, genomic and transcriptomic analysis are crucial tools in cancer research that enable the identification of genetic mutations and alterations that drive the development and progression of cancer. By studying the changes in the DNA and RNA sequences of cancer cells, researchers can gain insights into the underlying molecular mechanisms of cancer and identify potential therapeutic targets. Genomic analysis can identify specific mutations or alterations that are present in cancer cells, while transcriptomic analysis can reveal changes in gene expression that may be linked to disease progression or response to treatment. These analyses are an essential component for the development of precision medicine approaches, which aim to tailor cancer treatment to the individual genetic profile of each patient.
PDOs can replicate in vitro the biological, genetic and molecular aspects of the primary tumour. Some of their advantages include their rapid growth compared to xenografts, the possibility to perform high-throughput drug screening, and their direct application to precision oncology by predicting best therapies. In this study they will be used as an in vitro comparator of the molecular tests to the clinical course of the patient.
Overall, combining genomic and transcriptomic analysis with PDO technology in cancer research might lead to exponential capacity to provide oncologic patients with extremely tailored and effective cancer treatments in the future.
For HIPANC-002 these tests are being evaluated as non-interventional investigational IVD's. Test results are not to be used for protocol mandated therapy decisions.
Detailed description
Primary objective.
The study seeks primarily to demonstrate whether a significant correlation between the IVD based predicted drug sensitivity and the patient's progression-free survival (PFS) in metastatic pancreatic adenocarcinoma after administered standard therapies (which are not chosen based on the test) exist.
Secondary objectives. The study seeks further to
- Explore the correlation between Darwin-test predicted drug sensitivity and patient-derived PDO sensitivity to clinically used drug regimens.
- Explore the correlation between the measured PDO sensitivity to the administered standard therapies and the clinical course of the patient, i.e. PFS (in vivo and in vitro comparison).
- Collect samples for biobanking and future identification of potential new markers associated with tumor response.
Safety objectives.
The study aims to assess:
The rate and severity of 30-days post-operative surgical complications related to laparoscopic surgical biopsy required to retrieve tumoral tissue for IVD-based testing and PDO generation.
The primary outcome is achieved if a significant correlation between IVD based predictions of drug sensitivity and clinically observed patient outcome (progression-free survival after administered standard therapy) exist.
The secondary outcomes are achieved if
- There is a significant correlation between Darwin-test predicted drug sensitivity and patient-derived PDO sensitivity to clinically used drug regimens.
- There is a significant correlation between the measured PDO sensitivity to the administered standard therapies and the clinical course of the patient, i.e. PFS (in vivo and in vitro comparison).
Biobanked samples will be retrospectively analysed to highlight potential biochemical markers of tumour response to therapy if attributable.
The safety outcome will assess descriptively the rate of severe surgical post-operative complication related to laparoscopic surgical biopsy required to retrieve tumoral tissue for IVD-testing and PDO generation and occurring within 30 postoperative days.
Non-Interventional, single arm, observational study
Inclusion criteria:
- Informed Consent as documented by signature
- Patients older than 18 years
- Patients with metastatic pancreatic ductal adenocarcinoma
- At least one lesion amenable for surgical excisional biopsy
- ECOG Performance status 0-2
- Radiologically measurable disease
- Life expectancy > 3 months
- Absolute leucocyte count >1.5 G/l, platelets >100 G/l
- Serum creatinine <1.5 times of the upper limit of normal or Clearance >50ml/min (according to the CKD-EPI formula)
Exclusion criteria:
- Known allergies or intolerance to one or more compounds present in one of the first line or second line regimens
- Concomitant need for full anticoagulation that cannot be interrupted or bridged prior to tissue biopsy
- ECOG PS >2
- Heart failure (NYHA class III-IV)
- Severe or uncontrolled concurrent illness
- Active viral infection from HIV, HBV or HCV, even if under antiretroviral treatment
- Myocardial infarction within the previous 6 months
- Patients who are pregnant or breastfeeding
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Predictive value of Oncotreat/Oncotarget testing in palliative chemotherapy in pancreatic cancer | – | –The study will include patients with diagnosis of metastatic pancreatic adenocarcinoma. After complete disease staging, patients will undergo laparoscopic surgical biopsy of metastatic tumoral tissue. The tissue will serve for the generation of Oncotreat and Oncotarget tests as well as for patient-derived organoids on which potentially predicted drugs will be benchmarked. Each patient will receive the standard first-line and second-line chemotherapy (chosen among Gemcitabine-Abraxane, or Abraxane-Gemcitabine-FOLFOX or FOLFIRINOX, based on the clinical judgement of the treating oncologist). When progression occurs predictive value of the test with regard to Progression-free Survival (PFS) will be analyzed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with the diagnosis of metastatic adenocarcinoma of the pancreas can be enrolled provided the above mentioned criteria apply. The patients can either be therapy-naive or pretreated.
Key inclusion criteria (9 listed)
- Informed Consent as documented by signature
- Patients older than 18 years
- Patients with metastatic pancreatic ductal adenocarcinoma
- At least one lesion amenable for surgical excisional biopsy
- ECOG Performance status 0-2
Key exclusion criteria (8 listed)
- Known allergies or intolerance to one or more compounds present in one of the first line or second line regimens
- Concomitant need for full anticoagulation that cannot be interrupted or bridged prior to tissue biopsy
- ECOG PS >2
- Heart failure (NYHA class III-IV)
- Severe or uncontrolled concurrent illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Is there a significant correlation between Oncotarget/Oncotreat based predicted drug sensitivity and the patient's progression-free survival (PFS) in metastatic pancreatic adenocarcinoma after administered standard therapy ?
Time frame: From enrollment to disease progression according to the RECIST v1.1 criteria, assessed up to 100 months
To demonstrate a significant correlation between the degree of sensitivity predicted by Oncotreat/Oncotarget to Gemcitabine-Abraxane, or Abraxane-Gemcitabine-FOLFOX (according to the SEQUENCE trial) or FOLFIRINOX (according to the NAPOLI-3 trial), and clinical progression free survival (PFS) in metastatic pancreatic adenocarcinoma.
1 secondary outcome
1) Correlation between Darwin-test predicted drug sensitivity and patient-derived PDO sensitivity to clinically used drug regimens. 2) Correlation between the measured PDO sensitivity to the administered standard therapies 3) Biobanking
Time frame: Observation until progression under given standard treatment using RECIST and TU markers. Follow up until progression and/or death at least 60 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Results publication: PubMed 8580930Morikawa T, Yoshida M. A useful testing strategy in phase III trials: combined test of superiority and test of equivalence. J Biopharm Stat. 1995 Nov;5(3):297-306. doi: 10.1080/10543409508835115.
- Results publication: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Results publication: PubMed 32558804Paluri RK, Kasi A, Young C, Posey JA. Second-line treatment for metastatic pancreatic cancer. Clin Adv Hematol Oncol. 2020 Feb;18(2):106-115.
- Results publication: PubMed 34665339Ettrich TJ, Seufferlein T. Systemic Therapy for Metastatic Pancreatic Cancer. Curr Treat Options Oncol. 2021 Oct 19;22(11):106. doi: 10.1007/s11864-021-00895-4.
- Results publication: PubMed 28353074Zhang XW, Ma YX, Sun Y, Cao YB, Li Q, Xu CA. Gemcitabine in Combination with a Second Cytotoxic Agent in the First-Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer: a Systematic Review and Meta-Analysis. Target Oncol. 2017 Jun;12(3):309-321. doi: 10.1007/s11523-017-0486-5.
- Results publication: PubMed 19801936Nguyen KT, Gamblin TC, Geller DA. World review of laparoscopic liver resection-2,804 patients. Ann Surg. 2009 Nov;250(5):831-41. doi: 10.1097/SLA.0b013e3181b0c4df.
- Results publication: PubMed 17051446Strassburg CP, Manns MP. Approaches to liver biopsy techniques--revisited. Semin Liver Dis. 2006 Nov;26(4):318-27. doi: 10.1055/s-2006-951599.
- Results publication: PubMed 36374194Vasciaveo A, Arriaga JM, de Almeida FN, Zou M, Douglass EF, Picech F, Shibata M, Rodriguez-Calero A, de Brot S, Mitrofanova A, Chua CW, Karan C, Realubit R, Pampou S, Kim JY, Afari SN, Mukhammadov T, Zanella L, Corey E, Alvarez MJ, Rubin MA, Shen MM, Califano A, Abate-Shen C. OncoLoop: A Network-Based Precision Cancer Medicine Framework. Cancer Discov. 2023 Feb 6;13(2):386-409. doi: 10.1158/2159-8290.CD-22-0342.
- Results publication: PubMed 30430011Yang H, Sun L, Liu M, Mao Y. Patient-derived organoids: a promising model for personalized cancer treatment. Gastroenterol Rep (Oxf). 2018 Nov;6(4):243-245. doi: 10.1093/gastro/goy040. Epub 2018 Oct 9. No abstract available.
- Results publication: PubMed 29325707Tiriac H, Bucobo JC, Tzimas D, Grewel S, Lacomb JF, Rowehl LM, Nagula S, Wu M, Kim J, Sasson A, Vignesh S, Martello L, Munoz-Sagastibelza M, Somma J, Tuveson DA, Li E, Buscaglia JM. Successful creation of pancreatic cancer organoids by means of EUS-guided fine-needle biopsy sampling for personalized cancer treatment. Gastrointest Endosc. 2018 Jun;87(6):1474-1480. doi: 10.1016/j.gie.2017.12.032. Epub 2018 Jan 9.
- Results publication: PubMed 30834048Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 2019 Feb;10(1):10-27. doi: 10.14740/wjon1166. Epub 2019 Feb 26.
- Results publication: PubMed 27956793Ilic M, Ilic I. Epidemiology of pancreatic cancer. World J Gastroenterol. 2016 Nov 28;22(44):9694-9705. doi: 10.3748/wjg.v22.i44.9694.
- 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.
Jan Schmidt, Prof. Dr. med. Dres. h.c., MME study director
Swiss Surgery/Hirslanden Zurich
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Neoplasms and Pancreatic Neoplasms, run by Prof. Dr. med. Dres. h.c. Jan Schmidt, MME.
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 9 inclusion and 8 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: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Schmidt, Prof. Dr. med. Dres. h.c. MME (+ 41 442092505, jan.schmidt@hirslanden.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is there a significant correlation between Oncotarget/Oncotreat based predicted drug sensitivity and the patient's progression-free survival (PFS) in metastatic pancreatic adenocarcinoma after administered standard therapy ? (time frame: From enrollment to disease progression according to the RECIST v1.1 criteria, assessed up to 100 months). 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 NCT06615830, which also lists 13 linked publications.
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 11 Feb 2026.