Molecularly Tailored Therapy in Advanced Pancreatic Cancer

Summary

Pancreatic cancer that has spread or cannot be removed by surgery is difficult to treat. Standard chemotherapy can slow the disease, but the cancer often starts growing again. Some pancreatic cancers have specific genetic changes that may be targeted by medicines already available in Denmark. It is not yet known whether selecting treatment based on these genetic changes is more effective than standard treatment.

TAILOR-PANC is a randomized phase 2 study evaluating treatment guided by the molecular characteristics of the cancer. Adults with advanced pancreatic cancer whose disease has progressed during or after first-line chemotherapy may participate if molecular testing results are available. A national molecular tumor board will review these results and determine whether the cancer has a genetic change that can be matched to an available targeted treatment.

Participants with a suitable genetic change will be randomly assigned in a 1:1 ratio to receive either the matched treatment recommended by the molecular tumor board or standard second-line treatment according to Danish guidelines. Participants without a suitable genetic change will receive standard treatment and will be followed in a separate observational group. Treatment will continue until the cancer progresses, unacceptable side effects occur, the participant withdraws consent, or the treating physician decides that treatment should stop.

The main purpose of the study is to determine whether molecularly matched treatment delays cancer progression compared with standard treatment. The study will also evaluate overall survival, tumor response, side effects, and quality of life. Participants in the randomized groups will undergo scans, blood tests, and quality-of-life assessments at baseline and approximately every 8 weeks. Optional blood and tumor samples may also be collected through the BIOPAC project to explore biomarkers that could help predict treatment response or side effects.

Conditions

• Pancreatic Cancer

Interventions

DRUG

Arm 1: Molecularly Tailored Therapy

Axitinib Crizotinib Dabrafenib Trametinib Erlotinib Larotrectinib Olaparib Pembrolizumab Pemigatinib Pertuzumab and trastuzumab (Phesgo9 Selpercatinib Vismodegib

DRUG

Arms 2: Standard-of-Care Therapy

Gemcitabine Nab-paclitaxel 5-Fluorouracil; 5-FU Calcium folinate Oxaliplatin Irinotecan Capecitabine

DRUG

Arm 3: Standard-of-Care Observational Cohort

Gemcitabine Nab-paclitaxel 5-Fluorouracil; 5-FU Calcium folinate Oxaliplatin Irinotecan Capecitabine

Sponsors & Collaborators

• Aalborg University Hospital

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Vejle Hospital

  collaborator OTHER

• Herlev Hospital

  lead OTHER

Principal Investigators

• Inna Markovna Chen, MD · Herlev Sygehus

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-31

Primary Completion

2031-06-30

Completion

2032-06-30

Countries

• Denmark

Study Locations