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2024-10
2028-12
2029-02
185
NCT06615830
Klinik Hirslanden, Zurich
Klinik Hirslanden, Zurich
INTERVENTIONAL
Organoid-driven Chemotherapy Choice in Metastatic Pancreatic Cancer Patients.
Pancreatic cancer is burdened by an extremely low survival rate. Survival chances reduce even further when the tumor spreads to other organs such as lymphnodes, liver or lungs. When the tumor cannot be surgically resected, the only valid curative option is represented by chemotherapy. However, therapies available to date have limited efficacy and they do not specifically target the biological characteristics of the tumor. The aim of the project is to validate a new technology called "patient-derived organoids" (PDOs) in predicting the best drugs for the treatment of pancreatic cancer based on the tumoral characteristics and behavior. In order to generate PDOs a sample of tumoral tissue will be collected during a small surgical procedure, called laparoscopy. PDOs represent mini, three-dimensional copies of the original tumor, of which they maintain its behavior and aggressiveness. Through the DNA and RNA analysis of the tumor, the aim is to predict the best available drug by screening thousands of potentially effective compounds. Once identified, drugs will be tested in vitro on PDOs and the most efficient drug in controlling the tumor will be administered to the patient, once the present standard-of-care treatments fail. Multiple benefits are expected from this trial. First of all, the most effective drug against their tumor based on an objective in vitro response will be provided. This might reflect in a better control of the disease and in a longer survival. Targeting the chemotherapy will also imply less side-effects due to unnecessary elevated chemotherapeutic dosages, which in turn will lead to a better compliance with the therapy. Eventually, all these aspects will reflect into a better quality of life.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-09-01 | N/A | 2024-09-23 |
2024-09-23 | N/A | 2024-09-27 |
2024-09-27 | N/A | 2024-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Organoid-driven second-line chemotherapy The arm will include patients with diagnosis of metastatic pancreatic adenocarcinoma. After complete disease staging, patients will undergo laparoscopic surgical biopsy of metastatic tumoral tissue. The tissue will serve for the generation of patient-deri | DRUG: Standard chemotherapy
DRUG: Organoid-guided treatment
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Organoid sensitivity to first-line regimens ad progression-free survival | To demonstrate a significant correlation between the degree of sensitivity predicted by PDOs to Gemcitabine-Abraxane, or Abraxane-Gemcitabine-FOLFOX (according to the SEQUENCE trial) or FOLFIRINOX (according to the NAPOLI-3 trial), and clinical progression free survival (PFS) in metastatic pancreatic adenocarcinoma. | From enrollment to disease progression according to the RECIST v1.1 criteria, assessed up to 100 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Linear versus non-linear relationship between organoid sensitivity and progression-free survival | Explore graphically and statistically whether the relationship between PDOs sensitivity to first line regimens and PFS has a linear or non-linear shape. | From patient-derived organoid generation to completion of drug benchmarking, assessed up to 100 months |
| Within-subjects progression-free survival comparison | Compare progression-free survival in months between second-line, targeted regimens with first-line, standard therapy. | From patient enrollment until second disease progression according to the RECIST v1.1 criteria, assessed up to 100 months |
| Linear versus non-linear relationship between organoid sensitivity and progression-free survival | Explore graphically and statistically whether the relationship between PDOs sensitivity to second-line, targeted regimens and PFS has a linear or non-linear shape. | From patient-derived organoid generation to completion of drug benchmarking assessed up to 100 months |
| Quality of life | Assess quality of life under standard and targeted chemotherapy. | From enrollment to the second disease progression according to the RECIST v1.1 criteria, assessed up to 100 months |
| Biobanking | Collect samples for biobanking and further identification of potential markers associated with tumor response (e.g. circulating tumoral DNA). | Biological samples will be biobanked up to 5 years |
| Rate of newly-identified compound | Assess the rate of compounds identified by patient-derived organoids, which are not routinely used by treating oncologists or accepted by insurances for reimbursement. | From patient-derived organoid generation to completion of drug benchmarking, through study completion, an average of 1 year |
| Second-line, most effective regimen in vitro prediction | Assess, through patient-derived organoids benchmarking, the most effective second-line chemotherapeutic regimen according to the presence of genetic signatures (at DNA and RNA level) associated with treatment response. | From patient-derived organoid generation to completion of drug benchmarking, through study completion, assessed up to 100 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Jan Schmidt, Prof. Dr. med. Dres. h.c. MME Phone Number: + 41 442092505 Email: jan.schmidt@hirslanden.ch |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
