Solid CancerESCAPENCT07114627
Impact of CES1 Genotype on Capecitabine Exposure in Cancer Patients
An observational study of Solid Cancer and Gastric (Cardia, Body) Cancer, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
In this study, the drug capecitabine is investigated. Capecitabine is commonly used to treat breast, colon, and stomach cancers. Capecitabine is taken in tablet form. In the body, capecitabine is converted into the active molecule that has anti-cancer effects. This molecule is called 5-FU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancer, Gastric (Cardia, Body) Cancer, Esophageal Cancer
- What is being tested?
- Blood sampling for pharmacokinetics
- How many people
- 66 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Feb 2025to Jun 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with cancer who are intended to start with CAPOX treatment.
Who may be able to join
None listed.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Carrier of a known clinically relevant DPYD variant (i.e. *2A, *7, *13, c.1236G>A or c.2846A>T);
- Any medical condition that is known to influence capecitabine absorption (i.e. a Roux-en-Y gastric bypass operation or complete gastric resection; an esophagectomy is not considered to impair absorption);
- Prior treatment with fluoropyrimidines;
- Use of DPD-inhibitors and/or allopurinol;
- Known pregnancy at baseline.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC Cancer Institute
Rotterdam, 3015GD
N. Heersche, 0031 10 7040704, n.heersche@erasmusmc.nl
About this study
Official title: Exploratory Study of Capecitabine Pharmacokinetics and Hand-foot Syndrome in CES1 Variant Carriers: the ESCAPE Study
In this study, the drug capecitabine is investigated. Capecitabine is commonly used to treat breast, colon, and stomach cancers. Capecitabine is taken in tablet form. In the body, capecitabine is converted into the active molecule that has anti-cancer effects. This molecule is called 5-FU. The transformation of capecitabine to 5-FU occurs through specific proteins in the liver, also known as enzymes.
Unfortunately, capecitabine can also cause side effects. One of the most common side effects is hand-foot syndrome. In hand-foot syndrome, the palms of the hands and soles of the feet become red and painful. Previous research has shown that patients in whom one of the enzymes responsible for converting capecitabine in the liver does not function properly experience an increase in side effects frequency, particularly severe hand-foot syndrome. This specific enzyme is called CES1. It is believed that side effects occur more frequently because capecitabine is transformed more slowly, eventually leading to a prolonged exposure to 5-FU in the body.
In roughly one in three people, this enzyme functions less efficiently. To gain a better understanding of how this mechanism works, we aim to conduct this study. In this study, we will examine if patients with a less effective CES1 enzyme have higher amounts of 5-FU in their blood. We will also look into whether these patients develop side effects, such as hand-foot syndrome, more frequently. This information could eventually help us develop new strategies to reduce side effects for these patients in the future.
- Being tested
- Blood sampling for pharmacokinetics
- Keywords
- CAPOX, CES1, carboxylesterase 1, Capecitabine, Pharmacokinetics, Pharmacogenetics, Oncology, SNP, Single-nucleotide polymorphism, rs2244613, Hand-foot syndrome, HFS, 5-FU, ErasmusMC, Cancer
- Medical subject headings
- Neoplasms, Esophageal Neoplasms, Colorectal Neoplasms, Hand-Foot Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling for pharmacokineticsDrug
Extra blood samples are collected for assement of the pharmacokinetics of capecitabine.
| Study group | Role | What they receive |
|---|---|---|
| Single-nucleotide polymorphism (SNP) | Oncological patients who are treated with CAPOX (with or without additional anti-neoplastic agents, including but not limited to nivolumab, trastuzumab or bevacizumab) according to standard of care. These patients are known carriers of the CES1 1165-33 C>A (rs2244613) SNP. Receives: Drug: Blood sampling for pharmacokinetics | |
| Wild type | Oncological patients who are treated with CAPOX (with or without additional anti-neoplastic agents, including but not limited to nivolumab, trastuzumab or bevacizumab) according to standard of care. These patients are known carriers of the wild-type CES1 gene. Receives: Drug: Blood sampling for pharmacokinetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Exposure
Difference in Area Under the Curve (AUC)
Measured: Up to 6 hours after intake of capecitabine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start18 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid CancerStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niels Heersche, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114627
- Sponsor's protocol ID
- MEC 2024-0518
- Other IDs
- 2024-516788-96-00
- Acronym
- ESCAPE
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Capecitabine Pharmacokinetics and Hand-foot Syndrome in CES1 Variant Carriers: the ESCAPE Study
- ClinicalTrials.gov ID
- NCT07114627
- Acronym / sponsor ID
- ESCAPE / MEC 2024-0518
- Keywords
- CAPOX, CES1, carboxylesterase 1, Capecitabine, Pharmacokinetics, Pharmacogenetics, Oncology, SNP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the drug capecitabine is investigated. Capecitabine is commonly used to treat breast, colon, and stomach cancers. Capecitabine is taken in tablet form. In the body, capecitabine is converted into the active molecule that has anti-cancer effects. This molecule is called 5-FU. The transformation of capecitabine to 5-FU occurs through specific proteins in the liver, also known as enzymes.
Unfortunately, capecitabine can also cause side effects. One of the most common side effects is hand-foot syndrome. In hand-foot syndrome, the palms of the hands and soles of the feet become red and painful. Previous research has shown that patients in whom one of the enzymes responsible for converting capecitabine in the liver does not function properly experience an increase in side effects frequency, particularly severe hand-foot syndrome. This specific enzyme is called CES1. It is believed that side effects occur more frequently because capecitabine is transformed more slowly, eventually leading to a prolonged exposure to 5-FU in the body.
In roughly one in three people, this enzyme functions less efficiently. To gain a better understanding of how this mechanism works, we aim to conduct this study. In this study, we will examine if patients with a less effective CES1 enzyme have higher amounts of 5-FU in their blood. We will also look into whether these patients develop side effects, such as hand-foot syndrome, more frequently. This information could eventually help us develop new strategies to reduce side effects for these patients in the future.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-nucleotide polymorphism (SNP) | – | Drug: Blood sampling for pharmacokineticsOncological patients who are treated with CAPOX (with or without additional anti-neoplastic agents, including but not limited to nivolumab, trastuzumab or bevacizumab) according to standard of care. These patients are known carriers of the CES1 1165-33 C>A (rs2244613) SNP. |
| Wild type | – | Drug: Blood sampling for pharmacokineticsOncological patients who are treated with CAPOX (with or without additional anti-neoplastic agents, including but not limited to nivolumab, trastuzumab or bevacizumab) according to standard of care. These patients are known carriers of the wild-type CES1 gene. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with cancer who are intended to start with CAPOX treatment.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Carrier of a known clinically relevant DPYD variant (i.e. *2A, *7, *13, c.1236G>A or c.2846A>T);
- Any medical condition that is known to influence capecitabine absorption (i.e. a Roux-en-Y gastric bypass operation or complete gastric resection; an esophagectomy is not considered to impair absorption);
- Prior treatment with fluoropyrimidines;
- Use of DPD-inhibitors and/or allopurinol;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling for pharmacokineticsExtra blood samples are collected for assement of the pharmacokinetics of capecitabine. | Drug | Single-nucleotide polymorphism (SNP), Wild type |
Primary outcome
Pharmacokinetic Exposure
Time frame: Up to 6 hours after intake of capecitabine
Difference in Area Under the Curve (AUC)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Cancer and Gastric (Cardia, Body) Cancer, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Exposure (time frame: Up to 6 hours after intake of capecitabine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.