Predictive Value of Analysing Tissue From Patients With Metastatic Pancreatic Cancer for Drug Sensitivity

Study Overview
=================
Brief Summary
-----------------
It will be investigated whether it is possible to predict the effect or lack of effect of first-line treatment by analysing cancer cells from the individual patient receiving standard first line treatment. Also, the feasibility of selecting second-line therapy based on pre-treatment biopsies will be investigated. Cells from pancreatic cancer will be grown in the laboratory to form small, circulating tumors and adjacent tissue, so called tumoroids. The tumoroids will then be exposed to different pre-specified anticancer drugs to hopefully reveal sensitivity or lack of sensitivity in the specific patient.

Official Title
-----------------
Predictive Value of In-vitro Anti-cancer Therapy Sensitivity Testing on Tumoroids From Patients With Metastatic Pancreatic Cancer

Conditions
-----------------
Metastatic Pancreatic Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Inditreat
* Drug: Experimental drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-resectable pancreatic cancer Biopsy proven adenocarcinoma compatible with pancreatic origin (primary tumor or metastasis) If only biopsy from metastasis can be obtained, the patient must have a previously resected or image proven tumor of the pancreas Deemed non-resectable at a multidisciplinary conference Candidate to standard systemic therapy, defined as one of Gemcitabine monotherapy, Gemcitabine and nab-paclitaxel combination, Gemcitabine and capecitabine combination, 5-fluorouracil, oxaliplatin and irinotecan combination (FOLFIRINOX), or New standard treatments approved by the multidisciplinary cancer group 'Danish Pancreatic Cancer Group' in the inclusion period. Measurable disease according to RECIST 1.1 ECOG performance status 0-2 Age at least 18 years Adequate bone marrow, liver and renal function allowing systemic chemotherapy Absolute neutrophil count ≥1.5x10^9/l and thrombocytes ≥ 100x10^9/l Bilirubin ≤ 3 x upper normal value and alanine aminotransferase ≤ 5 x upper normal value Calculated or measured renal glomerular filtration rate at least 30 mL/min Contraception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable Written and orally informed consent Exclusion Criteria: Potentially resectable disease Incapacity, frailty, disability, or comorbidity to a degree that according to the investigator is not compatible with participation in the protocol Other active malignant disease requiring therapy Other systemic anti-cancer therapy (palliative radiotherapy is allowed) Pregnant (positive pregnancy test) or breast feeding women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard treatment<br>Standard first line treatment | Diagnostic Test: Inditreat<br>* Tumoroid formation and drug sensitivity analysis<br>Drug: Experimental drug<br>* Second line treatment based on drug sensitivity analysis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of in-vitro testing | Predictive value is defined as the ability to correctly predict response or resistance to first-line chemotherapy | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of selecting second-line therapy based on pre-treatment biopsies as measured by treatment response (RESIST 1.1 criteria) |  | Every 2 months during treatment up to 180 days | 
| Feasibility of selecting second-line therapy based on pre-treatment biopsies as measured by progression free survival (PFS) |  | Every 2 months up to 12 months |