Skip to main content
OpenTrials
Completed

NCT Number: NCT03821870

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Departmen of Oncology, Vejle Hospital

Vejle, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inditreat

Diagnostic Test

Tumoroid formation and drug sensitivity analysis

Experimental drug

Drug

Second line treatment based on drug sensitivity analysis

Primary outcomes

  1. Predictive value of in-vitro testing

    Time frame: 2 months

    Predictive value is defined as the ability to correctly predict response or resistance to first-line chemotherapy

Secondary outcomes

  1. Feasibility of selecting second-line therapy based on pre-treatment biopsies as measured by treatment response (RESIST 1.1 criteria)

    Time frame: Every 2 months during treatment up to 180 days

  2. Feasibility of selecting second-line therapy based on pre-treatment biopsies as measured by progression free survival (PFS)

    Time frame: Every 2 months up to 12 months

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study title

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

Acronym: TIP

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Jan 30, 2019
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.