A Phase 2 interventional study of Arm 1: Molecularly Tailored Therapy and Arms 2: Standard-of-Care Therapy in Pancreatic Cancer, sponsored by Herlev Hospital. Not yet recruiting at 4 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Herlev Hospital · Phase 2, Interventional, and Treatment
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.
TAILOR-PANC (DPCG-02) is an investigator-initiated, multicenter, randomized phase 2 trial evaluating whether molecularly tailored second-line therapy improves outcomes compared with standard-of-care treatment in patients with advanced pancreatic cancer.
Although most pancreatic cancers harbor KRAS mutations, a smaller proportion contain potentially actionable molecular alterations, including selected mutations, gene fusions, amplifications, or biomarkers such as mismatch repair deficiency. Some of these alterations can be targeted by medicines that are already available in Denmark, although the medicines may have been developed or approved primarily for other cancer types. Observational studies suggest that patients with pancreatic cancer who receive treatment matched to an actionable alteration may have better outcomes than patients who receive non-matched treatment. However, this strategy has not been adequately evaluated in a randomized setting.
Molecular profiling is performed before study allocation using tumor tissue and/or blood. Whole-genome sequencing is preferred, but targeted next-generation sequencing or whole-exome sequencing may be used when whole-genome sequencing is unavailable. The results are summarized in a personalized molecular report. A national multidisciplinary molecular tumor board, including pancreatic cancer oncologists, molecular biologists, pathologists, and computational biologists, reviews the molecular findings and assesses whether an alteration is clinically actionable. A molecular alteration is considered actionable when it can be matched to a specific anticancer treatment supported by clinical evidence and the treatment is available and reimbursed in Denmark.
Participants whose cancers harbor an actionable, reimbursed molecular alteration are randomized in a 1:1 ratio to:
Arm 1: molecularly tailored therapy selected according to the recommendation of the national molecular tumor board; or Arm 2: standard second-line therapy according to Danish clinical guidelines.
Because the molecular alteration determines the matched treatment, participants assigned to Arm 1 may receive different targeted treatments. The relevant drug-specific requirements, safety monitoring, dose modifications, and discontinuation criteria will apply to each treatment.
Participants whose cancers do not harbor an actionable, reimbursed molecular alteration are assigned to Arm 3, a non-randomized observational cohort receiving standard-of-care therapy according to Danish guidelines. Data from this cohort will support exploratory comparisons and provide information about outcomes among genomically profiled patients without an available matched treatment. Comparisons involving Arm 3 will be interpreted as non-randomized because molecular characteristics and other prognostic factors may differ between the groups.
The primary randomized comparison is progression-free survival between Arms 1 and 2. Approximately 68 participants with actionable alterations are required for randomization, with approximately 65 progression-free survival events planned for the primary analysis. The study is designed to provide approximately 80% power at a two-sided significance level of 0.05 to detect a hazard ratio of 0.50. This corresponds to the design assumption of an increase in median progression-free survival from 3 months with standard therapy to 6 months with molecularly tailored therapy. These values are statistical assumptions and do not represent guaranteed treatment outcomes.
Because actionable alterations are expected in only approximately 5%-10% of patients with pancreatic cancer, up to 1,200 genomically profiled participants may be enrolled to identify the required number for the randomized comparison. Recruitment is expected to take approximately 4 years, with approximately 1 additional year of minimum follow-up for the primary analysis.
The study will also characterize overall survival, tumor response, duration of response, safety, and patient-reported quality of life. Optional translational research will be conducted through the BIOPAC project under separate consent. Blood and available tumor samples may be used to explore molecular and circulating biomarkers associated with treatment response, resistance, and toxicity. Clinical and genomic data may also be used in exploratory artificial intelligence and machine-learning analyses intended to develop predictive models and identify potential therapeutic targets. These biomarker and computational analyses are exploratory and are not used as validated clinical tests within this study.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Herlev Hospital is the lead sponsor of 201 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Notes:
Minimum time from first systemic therapy for advanced PC to progression should be at least 2 months
Serum creatinine ≤ 1.5 x ULN or ≥ 50 mL/min (using the Cockcroft-Gault formula)
Exclusion Criteria:
Allergies and Adverse Drug Reaction
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Arm 1: Molecularly Tailored 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.
Drug: Arms 2: Standard-of-Care Therapy
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.
Drug: Arm 3: Standard-of-Care Observational Cohort
Axitinib Crizotinib Dabrafenib Trametinib Erlotinib Larotrectinib Olaparib Pembrolizumab Pemigatinib Pertuzumab and trastuzumab (Phesgo9 Selpercatinib Vismodegib
Gemcitabine Nab-paclitaxel 5-Fluorouracil; 5-FU Calcium folinate Oxaliplatin Irinotecan Capecitabine
Gemcitabine Nab-paclitaxel 5-Fluorouracil; 5-FU Calcium folinate Oxaliplatin Irinotecan Capecitabine
This study also gives Pembrolizumab, Trastuzumab, Olaparib, Pertuzumab. No intervention listed here names it: that was found by reading the record.
Progression-Free Survival in Randomized Participants
Progression-free survival is defined as the time from the first dose of study treatment to investigator-assessed objective disease progression according to RECIST version 1.1 or death from any cause in the absence of documented progression, whichever occurs first. Participants without progression or death at the analysis will be censored at their latest evaluable RECIST assessment. The primary comparison is between molecularly tailored therapy (Arm 1) and standard-of-care therapy (Arm 2).
Time frame: 1 year
Overall Survival in Randomized Participants
Overall survival is defined as the time from the first dose of study treatment until death from any cause. Participants not known to have died at the time of analysis will be censored on the last date they were known to be alive. Overall survival will be compared between Arm 1 and Arm 2.
Time frame: 1 year
Overall Survival Rate at 6 Months
The proportion of randomized participants alive 6 months after the first dose of study treatment, estimated using the Kaplan-Meier method.
Time frame: 6 months
Overall Survival Rate at 12 Months
The proportion of randomized participants alive 12 months after the first dose of study treatment, estimated using the Kaplan-Meier method.
Time frame: 12 months
Confirmed Objective Response Rate
The percentage of randomized participants with a confirmed complete response or partial response according to investigator assessment using RECIST version 1.1. A response must be confirmed by repeat imaging performed at least 4 weeks after the response was first observed, with no evidence of progression between assessments.
Time frame: 1 year
Disease Control Rate at 4, 6, and 12 Months
The percentage of randomized participants with a best overall response of complete or partial response within the specified period or stable disease maintained for the corresponding minimum period, according to investigator assessment using RECIST version 1.1. Disease control will be assessed at 4, 6, and 12 months after treatment initiation.
Time frame: 12 months
Duration of Response
Among randomized participants with a documented complete or partial response, duration of response is defined as the time from the first documented response until objective disease progression according to RECIST version 1.1 or death from any cause in the absence of documented progression. Participants without progression or death following a response will be censored according to the progression-free survival censoring rules.
Time frame: 1 year
Progression-Free Survival After Subsequent Therapy
Progression-free survival 2 is defined for randomized participants receiving subsequent anticancer treatment after first disease progression as the time from the first dose of randomized study treatment until the second objective disease progression or death from any cause in the absence of second progression, whichever occurs first.
Time frame: 1 year
Incidence and Severity of Treatment-Related Adverse Events
The number and percentage of randomized participants experiencing adverse events, including serious adverse events, considered causally related to study treatment. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. Safety assessments also include deaths, laboratory findings, vital signs, electrocardiograms, and treatment exposure.
Time frame: 1 year
Change From Baseline in EORTC QLQ-C30 Scores
Adjusted mean change from baseline in the EORTC QLQ-C30 global health status/quality-of-life score and functional and symptom scales will be compared between randomized treatment arms. Scores will be calculated according to the EORTC scoring manual. Higher global health and functional scale scores indicate better functioning, whereas higher symptom scale scores indicate greater symptom burden.
Time frame: 1 year
Overall Survival Across Molecular and Treatment Cohorts
Overall survival will be explored by comparing molecularly tailored therapy in Arm 1 with standard-of-care therapy in Arm 3 and standard-of-care therapy in Arm 2 with standard-of-care therapy in Arm 3. Because Arm 3 includes participants without an actionable reimbursed molecular alteration and is not randomized, these comparisons are exploratory and may be affected by differences in molecular and clinical characteristics.
Time frame: 1 year
Objective Response Rate Across Molecular and Treatment Cohorts
Objective response rate will be explored by comparing Arm 1 with Arm 3 and Arm 2 with Arm 3. Objective response is defined as complete or partial response based on available investigator-assessed tumor evaluations. Comparisons involving Arm 3 are non-randomized and exploratory.
Time frame: 1 year
Correlations of Tumor and Blood Biomarkers With Clinical Outcomes
Exploratory biomarkers measured in available tumor tissue and peripheral blood before and during treatment will be summarized and evaluated for associations with objective response, best overall response, duration of response, disease control, progression-free survival, safety, and other clinical outcomes. Analyses will include baseline biomarker values and absolute or percentage changes from baseline. Biomarker sampling is optional through the BIOPAC project and requires separate consent.
Time frame: Up to 5 years
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2031, 56 months later.
Of 324 non-industry phase 2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 80. This study's planned 56 months is close to that.
Counting every sponsor, half of 393 studies reached it within 57 months; a quarter within 35 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Olaparib · Pertuzumab