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

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Pancreatic Cancer
• Intervention / Treatment: Diagnostic test: Inditreat; Drug: Experimental drug

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Denmark
  • Vejle, Denmark
    • Departmen of Oncology, Vejle Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with metastatic pancreatic cancer eligible for chemotherapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard treatment; Standard first line treatment	Diagnostic test: Inditreat; Tumoroid formation and drug sensitivity analysis; Drug: Experimental drug; Second line treatment based on drug sensitivity analysis

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	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

Collaborators and Investigators

• Sponsor: Vejle Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): February 22, 2023

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: TIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No