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Search / Trial NCT06615830

Organoid-driven Chemotherapy Choice in Metastatic Pancreatic Cancer Patients.

Launched by PROF. DR. MED. DRES. H.C. JAN SCHMIDT, MME · Sep 23, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Pancreatic Cancer Pancreatic Adenocarcinoma Metastatic Pancreatic Adenocarcinoma Organoid Organoid Driven Chemotherapy

ClinConnect Summary

This clinical trial is studying a new approach to treating metastatic pancreatic cancer, which is a type of cancer that has spread to other parts of the body. The goal is to use a technology called "patient-derived organoids" (PDOs) to help identify the best chemotherapy drugs for individual patients based on the specific characteristics of their tumors. To create these organoids, a small sample of tumor tissue will be collected during a minimally invasive procedure. Researchers will analyze this tissue to predict which drugs might work best for each patient, potentially leading to more effective treatment and fewer side effects.

To be eligible for this trial, participants need to be at least 18 years old and have metastatic pancreatic ductal adenocarcinoma, with at least one tumor that can be biopsied. They should also have a good performance status, meaning they are well enough to participate, and a life expectancy of more than three months. Those who take part can expect to receive personalized treatment based on the trial's findings, aiming for better control of their cancer and an improved quality of life. It's important to note that patients with certain health conditions or those who are pregnant or breastfeeding cannot join this trial.

Gender

ALL

Eligibility criteria

  • 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 3 first line regimens approved for the trial
  • 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

About Prof. Dr. Med. Dres. H.C. Jan Schmidt, Mme

Prof. Dr. Med. Dres. h.c. Jan Schmidt, MME, is a distinguished clinical trial sponsor renowned for his expertise in medical research and innovative therapeutic solutions. With a strong academic background and extensive experience in clinical methodologies, Prof. Schmidt leads initiatives aimed at advancing healthcare outcomes through rigorous trials and collaborative partnerships. His commitment to ethical standards and patient safety underpins all research endeavors, ensuring that each study contributes valuable insights to the medical community. Prof. Schmidt's leadership fosters a culture of excellence, driving forward the frontiers of medical knowledge and treatment efficacy.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported