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

• ClinicalTrials.gov Identifier: NCT03821870
• Recruitment Status: Recruiting
• First Posted: January 30, 2019
• Last Update Posted: April 27, 2022
• Sponsor: Vejle Hospital
• Information provided by (Responsible Party): Vejle Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Metastatic Pancreatic Cancer	Diagnostic Test: Inditreat; Drug: Experimental drug

Study Design

• Study Type: Observational
• Estimated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Predictive Value of In-vitro Anti-cancer Therapy Sensitivity Testing on Tumoroids From Patients With Metastatic Pancreatic Cancer
• Actual Study Start Date: February 25, 2019
• Actual Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 2023

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Biospecimen Retention:   Samples With DNA

Liver biopsy and blood samples

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients with metastatic pancreatic cancer eligible for chemotherapy

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

Contacts and Locations

Contacts

Contact: Lars Henrik Jensen, MD, PhD; +45 7940 6802; lars.henrik.jensen@rsyd.dk

Locations

Denmark

Departmen of Oncology, Vejle Hospital; Recruiting

Vejle, Denmark

Contact: Lars H Jensen, MD lars.henrik.jensen@rsyd.dk

Sponsors and Collaborators

Vejle Hospital

Investigators

• Study Chair: Lars Henrik Jensen, MD, PhD; Vejle Hospital

More Information

• Responsible Party: Vejle Hospital
• ClinicalTrials.gov Identifier: NCT03821870
• Other Study ID Numbers: TIP
• First Posted: January 30, 2019
• Last Update Posted: April 27, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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