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

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Conditions studied: Pancreas Neoplasms, Pancreatic Neoplasms, Pancreatic Cancer Metastatic, Pancreatic Adenocarcinoma Metastatic

In brief

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.

Key facts

Study ID: NCT06615830
Run by: Prof. Dr. med. Dres. h.c. Jan Schmidt, MME
People needed: 185
Starts: 2026-06-01
Expected to finish: 2031-01-01
Last updated by the study team: 2026-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Full record on ClinicalTrials.gov

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