Predictive Value of Transcriptome-based OncoTreat/Oncotarget and Organoid Testing in Metastatic Pancreatic Cancer.

February 7, 2026 updated by: Prof. Dr. med. Dres. h.c. Jan Schmidt, MME

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

  1. Explore the correlation between Darwin-test predicted drug sensitivity and patient-derived PDO sensitivity to clinically used drug regimens.
  2. 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).
  3. 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

  1. There is a significant correlation between Darwin-test predicted drug sensitivity and patient-derived PDO sensitivity to clinically used drug regimens.
  2. 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 Type

Observational

Enrollment (Estimated)

185

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to disease progression according to the RECIST v1.1 criteria, assessed up to 100 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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.
Observation until progression under given standard treatment using RECIST and TU markers. Follow up until progression and/or death at least 60 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. med. Dres. h.c. Jan Schmidt, MME

Collaborators

Klinik Hirslanden, Zurich
Columbia Research Laboratories
Insel Gruppe AG, University Hospital Bern

Investigators

  • Study Director: Jan Schmidt, Prof. Dr. med. Dres. h.c., MME, Swiss Surgery/Hirslanden Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

September 1, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 7, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIPANC_002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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