Clinical trial NCT05351983: Patient-derived Organoids Drug Screen in Pancreatic Cancer
Official title: Patient-derived Organoid Generation in Pancreatic Cancer: a Single Centre, Open-label, Single Arm Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreas Cancer
Pancreas Neoplasm
Pancreas Adenocarcinoma
Pancreatic Cancer
Pancreatic Neoplasms
Pancreatic Adenocarcinoma
Lead sponsor: Klinik Hirslanden, Zurich
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 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 criteria:

* 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
* Myocardial infarction within the previous 6 months

Primary outcomes:
measure: Feasibility of the process
timeFrame: 30 days after the last patient enrollment.
Secondary outcomes:
measure: Safety of surgical biopsy and post-operative surgical complications.
timeFrame: 30 days post-operatively
measure: Contamination rates
timeFrame: 30 days after the last patient enrollment.
measure: Chemosensitivity testing
timeFrame: 6 days after the last organoid generation
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Hirslanden Kliniks
Study officials:
affiliation: Onkozentrum Zürich
name: Daniel Helbling, Dr. Med.
role: STUDY_CHAIR
affiliation: University of Bern
name: Marianna Kruithof-De Julio, Prof. Dr. phil.
role: STUDY_CHAIR
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