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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment | Standard first line treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inditreat | Diagnostic Test | Tumoroid formation and drug sensitivity analysis |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Non-resectable pancreatic cancer
Candidate to standard systemic therapy, defined as one of
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
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
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Patients with metastatic pancreatic cancer eligible for chemotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Lars Henrik Jensen, MD, PhD | Vejle Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departmen of Oncology, Vejle Hospital | Vejle | Denmark |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D015507 | Drugs, Investigational |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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Liver biopsy and blood samples
| Experimental drug |
| Drug |
Second line treatment based on drug sensitivity analysis |
|
| Every 2 months up to 12 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |