Patient-derived Organoids Drug Screen in Pancreatic Cancer

Last updated: September 20, 2025
Sponsor: Prof. Dr. med. Dres. h.c. Jan Schmidt, MME
Overall Status: Completed

Phase

N/A

Condition

Pancreatic Cancer

Adenocarcinoma

Cancer

Treatment

Surgical biopsy of tumoral tissue for organoid generation

Clinical Study ID

NCT05351983
HIRSLANDEN_PANC_001
  • Ages 18-100
  • All Genders

Study Summary

Few chemotherapeutic options exist for pancreatic cancer. Moreover, objective criteria are lacking for deciding which regimen is more beneficial for patient presenting with metastases at diagnosis.

This study investigates whether organoid generation from tumour samples of pancreatic cancer is a safe and feasible process for testing of multiple chemotherapy regimens in the laboratory.

By participating to this study, patients will have a part of the tumour tissue retrieved and sent to the laboratory for organoid generation and drug testing. For surgically-resectable tumors, tumoral tissue samples will be collected from the main surgical specimens, before sending it for final pathological examination. In case of suspected metastatic lesion at diagnosis, curative surgery is not indicated. Therefore, we will offer patients to undergo port-a-cath implantation for chemotherapy delivery and concomitant laparoscopic surgical excisional biopsy of suspicious metastatic (either hepatic or peritoneal) lesions.

At this stage of the study, the treatment that the patient will receive after surgery will not be affected by the results of the laboratory testing. In fact, all patients will receive the standard of care treatment based on the most recent oncologic guidelines and on the oncologist's clinical judgement. As part of the study, each patient will be followed for 30 days to assess possible surgical complications related to the surgical biopsy.

This study will help to speed up the implementation of organoid generation in the clinical routine for the choice of the best treatment of patients affected by pancreatic cancer.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Written informed consent provided

  • Patients older than 18 years

  • Histologically- or cytologically-proven pancreatic ductal adenocarcinoma (PDAC)

  • Tumour lesion amenable for laparoscopic, surgical biopsy

  • Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2

  • Radiologically measurable disease

  • Life expectancy > 3 months

  • Absolute neutrophile count >1500/microL, platelets >100'000/microL

  • Serum creatinine <1.5 times of the upper limit of normal or Clearance >50ml/min (according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)formula)

Exclusion

Exclusion criteria:

  • Concomitant need for full anticoagulation that cannot be interrupted or bridgedprior to tissue biopsy

  • ECOG PS >2

  • Heart failure (NYHA class III-IV)

  • Severe or uncontrolled concurrent illness

  • Myocardial infarction within the previous 6 months

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Surgical biopsy of tumoral tissue for organoid generation
Phase:
Study Start date:
September 22, 2022
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Hirslanden Kliniks

    Zurich 2657896, Canton of Zurich 2657895 8002
    Switzerland

    Site Not Available

  • Hirslanden Kliniks

    Zürich, 8002
    Switzerland

    Site Not Available

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