Patient-derived Organoids Drug Screen in Pancreatic Cancer

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

Status: Completed

Conditions: Pancreas Adenocarcinoma; Pancreatic Adenocarcinoma; Pancreas Cancer; Pancreas Neoplasm; Pancreatic Neoplasms; Pancreatic Cancer

Treatments: Procedure: Surgical biopsy of tumoral tissue for organoid generation

Study type: Interventional

Funder types: Other

Identifiers

NCT05351983

HIRSLANDEN_PANC_001

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Organoid generation

Experimental group

Description:

All patients will included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation.

Treatment:

Procedure: Surgical biopsy of tumoral tissue for organoid generation