Molecularly Tailored Therapy in Advanced Pancreatic Cancer

Conditions

• Pancreatic Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Arm 1: Molecularly Tailored Therapy — DRUG
  Axitinib Crizotinib Dabrafenib Trametinib Erlotinib Larotrectinib Olaparib Pembrolizumab Pemigatinib Pertuzumab and trastuzumab (Phesgo9 Selpercatinib Vismodegib
• Arms 2: Standard-of-Care Therapy — DRUG
  Gemcitabine Nab-paclitaxel 5-Fluorouracil; 5-FU Calcium folinate Oxaliplatin Irinotecan Capecitabine
• Arm 3: Standard-of-Care Observational Cohort — DRUG
  Gemcitabine Nab-paclitaxel 5-Fluorouracil; 5-FU Calcium folinate Oxaliplatin Irinotecan Capecitabine

Study Details

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.

Key Dates

First listed

Sep 3, 2026

Start date

Oct 31, 2026

Status verified

Aug 2026

Primary completion

Jun 30, 2031

Completion

Jun 30, 2032

Study Design

Enrollment

1,200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: Molecularly Tailored Therapy
  Participants with an actionable, reimbursed molecular alteration will receive molecularly tailored treatment selected on a case-by-case basis following review by the national molecular tumor board. The treatment will be matched to the identified alteration and may differ between participants. Treatment will be administered according to the relevant drug-specific requirements and continued until disease progression, unacceptable toxicity, withdrawal of consent, or clinical deterioration based on the investigator's judgment.
• Active Comparator: Arm 2: Standard-of-Care Therapy
  Participants with an actionable, reimbursed molecular alteration who are randomized to this arm will receive standard second-line systemic therapy according to current Danish clinical guidelines. The specific treatment will be selected by the treating investigator based on previous therapy, clinical condition, and applicable guidelines. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or clinical deterioration based on the investigator's judgment.
• Other: Arm 3: Standard-of-Care Observational Cohort
  Participants without an actionable, reimbursed molecular alteration will not undergo randomization. They will receive standard-of-care therapy according to current Danish clinical guidelines and will be followed as a non-randomized observational cohort. Treatment selection, assessments, and follow-up will be performed as part of routine clinical care. Data from this cohort will support exploratory comparisons with participants whose cancers contain actionable molecular alterations.

Primary Outcome Measure

Progression-Free Survival in Randomized Participants [ Time Frame: 1 year ]

Central Contacts

• Inna Markovna Chen, MD
  +45 38682898
  [email protected]
• Kevin Zi Ming Lim, MD
  +45 38689134
  [email protected]

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