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

NCT ID: NCT03821870

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-25
• Study Completion Date: 2023-02-22

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.

Conditions

Metastatic Pancreatic Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Standard treatment

Standard first line treatment

Inditreat

Intervention Type: DIAGNOSTIC_TEST

Tumoroid formation and drug sensitivity analysis

Experimental drug

Intervention Type: DRUG

Second line treatment based on drug sensitivity analysis

Interventions

Inditreat

Tumoroid formation and drug sensitivity analysis

Intervention Type: DIAGNOSTIC_TEST

Experimental drug

Second line treatment based on drug sensitivity analysis

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vejle Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lars Henrik Jensen, MD, PhD

Role: STUDY_CHAIR

Vejle Hospital

Locations

Departmen of Oncology, Vejle Hospital

Vejle, , Denmark

Countries

Denmark

Other Identifiers

TIP

Identifier Type: -

Identifier Source: org_study_id