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

NCT03821870 | Completed

• 1 other identifier: TIP
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Standard treatment

Standard first line treatment

Diagnostic Test: Inditreat; Drug: Experimental drug

Interventions

Inditreat DIAGNOSTIC_TEST

Tumoroid formation and drug sensitivity analysis

Standard treatment

Experimental drug DRUG

Second line treatment based on drug sensitivity analysis

Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with metastatic pancreatic cancer eligible for chemotherapy

You may qualify if:

• 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,
• fluorouracil, oxaliplatin and irinotecan combination (FOLFIRINOX), or
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Departmen of Oncology, Vejle Hospital

Vejle, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Liver biopsy and blood samples

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drugs, Investigational

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Lars Henrik Jensen, MD, PhD

  Vejle Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 30, 2019
• Study Start: February 25, 2019
• Primary Completion: December 31, 2021
• Study Completion: February 22, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)