“STUDY ON THE SELECTION OF CANCER MEDICATIONS USING CULTURED 'MINI-TUMOR COPIES' ('ORGANOIDS') AND MOLECULAR TESTING IN ADVANCED PANCREATIC CANCER“
Descrizione riassuntiva dello studio
In this study, we investigate how meaningful the testing of additional drug groups on small tumor copies ('organoids') is, and whether this method is effective and safe for determining the better or worse efficacy of study medications. Additionally, the tumor cells will be tested for their molecular characteristics, which may provide insights into their sensitivity or resistance to drug groups in individual cases.
(BASEC)
Intervento studiato
At the beginning of the study, a laparoscopy will be performed to obtain some tumor tissue ('Biopsy No. 1'). The laparoscopy is done under general anesthesia. A biopsy would also be necessary if the patient does not participate in the study. From this tissue, small tumor copies are cultured in the laboratory, known as 'organoids'. Furthermore, the tumor tissue will be examined for its molecular properties using specialized tests. If any of these control examinations show disease progression (a so-called 'progress'), the treatment will be switched to another chemotherapy. This new therapy will be selected based on the insights gained from the molecular examinations of the tumor tissue taken during the biopsy and the behavior of the small tumor copies against the tested medications. Before the start of this new chemotherapy phase, another laparoscopy will be performed under general anesthesia, and new biopsies of the tumor will be taken ('Biopsy No. 2'). Small tumor copies will again be cultured from these already 'treated' tumor cells, and they will be molecularly examined once more to gain further insights into tumor behavior and to select additional therapy options.
(BASEC)
Malattie studiate
METASTATIC PANCREATIC CANCER
(BASEC)
• Signed patient information including completed patient information • Patients older than 18 years • Patients with metastatic pancreatic cancer • At least one tumor lesion accessible for surgical biopsy • ECOG status 0-2 • Radiologically measurable disease • Life expectancy > 3 months • Leukocyte count >1.5 G/l, platelet count >100 G/l • Serum creatinine <1.5 x upper normal range or clearance >50ml/min (CKD-EPI formula) (BASEC)
Criteri di esclusione
• Known allergies or intolerances to the medications used for first-line chemotherapy • Necessity for total anticoagulation that cannot be interrupted for a biopsy • ECOG PS >2 • Heart failure (NYHA class III-IV) • Severe uncontrolled comorbidity • Active viral infection (HIV, HBV, or HCV, even under antiviral therapy) • Myocardial infarction within the last 6 months • Pregnant or breastfeeding patients (BASEC)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
PROF. DR. MED. JAN SCHMIDT KAPPELISTRASSE 7 8002 ZUERICH
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Dres. h.c. Jan Schmidt, MME Senior Visceral Surgeon SWISS SURGERY Hirslanden Clinics, Zürich (CH) Kappelistrasse 7, 8002 Zürich
+41 44 209 25 05
jan.schmidt@clutterhirslanden.chSWISS SURGERY HIRSLANDEN KLINIKEN ZÜRICH
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
31.03.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
«SINGLE-CENTRE, PHASE 2, OPEN LABEL, TWO INDEPENDENT ARMS STUDY ASSESSING MOLECULAR- AND ORGANOID-DRIVEN TUMORAL CHEMOSENSITIVITY IN METASTASTITC PANCREATIC CANCER» (BASEC)
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
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