Metastatic Pancreatic CancerPhase 2NCT05929885
Metronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients
A Phase 2 study testing Low Dose OXIRI (LD-OXIRI) in people with Metastatic Pancreatic Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
This is a single-centre, non-randomized, open label phase II trial to be conducted at the National Cancer Centre, Singapore (NCCS). Patients diagnosed with metastatic PDAC will be eligible to enrol. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Low Dose OXIRI (LD-OXIRI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 30 Aug 2023to 28 Feb 2027
- Phase
- Phase 2
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must meet all of the inclusion criteria to participate in the study.
- Aged above 21
- Histopathological diagnosis of pancreatic cancer
- Advanced disease not amenable to curative resection (locally advanced or metastatic disease)
- Measureable disease by RECIST 1.1 criteria
- Life expectancy of at least 12 weeks
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate hematologic function (granulocyte count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L),
- Adequate hepatic function (total bilirubin ≤ 1.5 x the upper limits of normal [ULN], AST and ALT, ALP ≤ 3 x ULN or < 5 x ULN in case of hepatic involvement),
- Adequate renal function (creatinine clearance > 50 mL/min) will be eligible for inclusion into the study.
- Able to provide written and informed consent
Who cannot join
- Any patient meeting any of the exclusion criteria at baseline will be excluded from participation.
- History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free after definitive primary treatment for at least 5 years.
- Untreated CNS metastases or leptomeningeal disease. Patients with brain metastases that have been treated, and are asymptomatic, and have been stable for 3 or more months after treatment are allowed. A baseline CT or MRI brain is only required if there is clinical suspicion of CNS involvement.
- Concurrent illness, including severe infection, that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
- Treatment with palliative chemotherapy or radiotherapy within 4 weeks prior to enrolment into the study
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- Major surgery within two weeks prior to enrolment into the study
- Patients on chronic immunosuppressive therapy
- Pregnancy, lactation or inadequate contraception. Women of childbearing potential must have a negative pregnancy test within 3 days of enrolment and agree to use a reliable means of contraception. Men must have been surgically sterilised or agree to use a barrier method of contraception
- Patients on anticoagulant therapy with vitamin K antagonists.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre, Singapore
Singapore, 168583
Dr Joycelyn LEE, MBBS, MRCP, M Med
About this study
Official title: A Phase II Study of Metronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients.
This is a single-centre, non-randomized, open label phase II trial to be conducted at the National Cancer Centre, Singapore (NCCS). Patients diagnosed with metastatic PDAC will be eligible to enrol.
The investigators hypothesize the anticancer activity of low dose OXIRI (LD-OXIRI) regimen comprising of metronomic oxaliplatin (O) and metronomic capecitabine (xeloda; X) in combination with UGT1A1-directed dosing of irinotecan (IRI) to be a tolerable regimen in patients with advanced PDAC and will lead to a favourable response rate.
Patients will be prospectively enrolled in two stages - In stage 1, patients will be recruited and evaluated for response and toxicity. In stage 2, more patients will be recruited for further evaluation of response and toxicity.
Read the detailed description
Eligible patients will be recruited from the National Cancer Centre, Singapore (NCCS). Patients will be referred for assessment by the primary physician to a study investigator for screening. Informed written consent for entry into the trial will be obtained from the patient by a delegated investigator.
All patients eligible for study entry will receive the LD-OXIRI regimen at the National Cancer Centre, Singapore. All concomitant medication taken during the study must be recorded. If a drug is administered prophylactically, this must be noted. The patients will not receive any other investigational drugs while on this study.
There will be a screening period of 28 days, a treatment period till disease progression or unacceptable toxicity, and a post-treatment follow up period of up to 24 months.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Low Dose OXIRI (LD-OXIRI)
- Keywords
- Low Dose OXIRI (LDOXIRI), Pancreatic Cancer, Irinotecan, Oxaliplatin, Capecitabine, Pharmacokinetics, Metronomic Chemotherapy, UGT1A1
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose OXIRI (LD-OXIRI)Drug
The LD-OXIRI regimen will be administered in the following sequence:
- metronomic capecitabine (Xeloda; X) 650mg/m2 will administered twice a day on a daily a continuous basis;
- intravenous metronomic oxaliplatin (O) 50 mg/m2 will be infused over 120 minutes on days 1 and 8 of a 21 day-cycle; followed by
- intravenous irinotecan (I) will be infused over 90 minutes on days 1 and 8 of a 21 day-cycle. The dose of irinotecan will be based on the particular patient's UGT1A1*6 and UGT1A1*28 genotype status.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose OXIRI (LD-OXIRI) | Experimental | Low Dose OXIRI (LD-OXIRI) regimen comprises Metronomic Oxaliplatin (O) and Metronomic Capecitabine (xeloda; X) in combination with UGT1A1-directed dosing of Irinotecan (IRI). Receives: Drug: Low Dose OXIRI (LD-OXIRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR).
The proportion of patients who have a partial or complete response as specified in RECIST 1.1.
Measured: Up to 3 years.
Clinical Benefit Rate (CBR).
The percentage of advanced cancer patients who achieve complete response, partial response, or at least six months of stable disease as specified in RECIST 1.1.
Measured: Up to 3 years.
The Grade 3-5 Toxicity Rate.
The proportion of patients who have adverse event(s) with Grade 3-5 toxicity as defined in CTCAE 5.0.
Measured: Up to 3 years.
Secondary outcomes (7)
Maximum plasma concentration [(Cmax)] of low dose Capecitabine and its intermediary metabolites (5'-deoxy-5-fluorocytidine [DFCR] and 5'- deoxy-5-fluorouridine [DFUR]) and 5FU.
Maximum plasma concentration [(Cmax)] of low dose capecitabine and its intermediary metabolites (5'-deoxy-5-fluorocytidine [DFCR] and 5'- deoxy-5-fluorouridine [DFUR]) and 5FU at Cycle 1 Day 1.
Measured: At predose, 1 hr, end of irinotecan infusion on Cycle 1 Day 1 (each cycle is 21 days)
Trough concentration of low dose capecitabine and its intermediary metabolites and 5FU.
Trough concentration of low dose capecitabine and its intermediary metabolites (5'-deoxy-5-fluorocytidine [DFCR] and 5'- deoxy-5-fluorouridine [DFUR]) and 5FU.
Measured: At predose of Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 21 days)
Immunophenotyping from extracted peripheral blood mononuclear cells (PBMCs) - measurement of cytokine and chemokine concentrations in picograms per milliliters using multiplex flow cytometry.
Immunophenotyping from extracted peripheral blood mononuclear cells (PBMCs) - measurement of cytokine and chemokine concentrations in picograms per milliliters using multiplex flow cytometry at these time-points: at predose, end of oxaliplatin infusion, end of irinotecan infusion on Cycle 1 Day 1 (each cycle is 21 days); at predose of Cycle 2 Day 1 and at disease progression (up to three years).
Measured: Up to 3 years.
Genomic analysis of circulating tumour DNA (ctDNA).
Genomic analysis of circulating tumour DNA (ctDNA) from whole blood at these time-points: at predose of every two cycles (Cycle 1 Day 1, Cycle 3 Day 1, Cycle 5 Day 1, etc - each cycle is 21 days) and at disease progression (up to three years).
Measured: Up to 3 years.
Identification of exosomal proteins secreted by extracellular vesicles from plasma.
Identification of exosomal proteins secreted by extracellular vesicles from plasma using mass spectrometry, at the following time-points: at predose, end of oxaliplatin infusion, end of irinotecan infusion on Cycle 1 Day 1 (each cycle is 21 days); at predose of Cycle 2 Day 1 and at disease progression (up to three years).
Measured: Up to 3 years.
Progression-free survival (PFS).
Time from first dose of treatment to disease progression or death, whichever comes first.
Measured: Up to 3 years.
Overall survival (OS).
Time from first dose to death.
Measured: Up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start30 Aug 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 43 patients will be enrolled in two stages - In stage 1, a total of 19 patients will be recruited and evaluated for response and toxicity. In stage 2, another 24 patients will be recruited for further evaluation of response and toxicity. Up to 7 patients will be recruited to account for any drop outs (i.e. up to total of 50 patients).
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor
- Investigators
- Dr Joycelyn LEE, MBBS, MRCP (UK), M Med, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929885
- Sponsor's protocol ID
- LDOXIRI-PDAC-01
- Status last verified
- Jun 2026
- First submitted
- 24 Apr 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Metronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients.
- ClinicalTrials.gov ID
- NCT05929885
- Acronym / sponsor ID
- LDOXIRI-PDAC-01
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- Low Dose OXIRI (LDOXIRI), Pancreatic Cancer, Irinotecan, Oxaliplatin, Capecitabine, Pharmacokinetics, Metronomic Chemotherapy, UGT1A1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 3 Jul 2023 (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.
This is a single-centre, non-randomized, open label phase II trial to be conducted at the National Cancer Centre, Singapore (NCCS). Patients diagnosed with metastatic PDAC will be eligible to enrol.
The investigators hypothesize the anticancer activity of low dose OXIRI (LD-OXIRI) regimen comprising of metronomic oxaliplatin (O) and metronomic capecitabine (xeloda; X) in combination with UGT1A1-directed dosing of irinotecan (IRI) to be a tolerable regimen in patients with advanced PDAC and will lead to a favourable response rate.
Patients will be prospectively enrolled in two stages - In stage 1, patients will be recruited and evaluated for response and toxicity. In stage 2, more patients will be recruited for further evaluation of response and toxicity.
Detailed description
Eligible patients will be recruited from the National Cancer Centre, Singapore (NCCS). Patients will be referred for assessment by the primary physician to a study investigator for screening. Informed written consent for entry into the trial will be obtained from the patient by a delegated investigator.
All patients eligible for study entry will receive the LD-OXIRI regimen at the National Cancer Centre, Singapore. All concomitant medication taken during the study must be recorded. If a drug is administered prophylactically, this must be noted. The patients will not receive any other investigational drugs while on this study.
There will be a screening period of 28 days, a treatment period till disease progression or unacceptable toxicity, and a post-treatment follow up period of up to 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 43 patients will be enrolled in two stages - In stage 1, a total of 19 patients will be recruited and evaluated for response and toxicity. In stage 2, another 24 patients will be recruited for further evaluation of response and toxicity. Up to 7 patients will be recruited to account for any drop outs (i.e. up to total of 50 patients).
| Arm | Type | Receives |
|---|---|---|
| Low Dose OXIRI (LD-OXIRI) | Experimental | Drug: Low Dose OXIRI (LD-OXIRI)Low Dose OXIRI (LD-OXIRI) regimen comprises Metronomic Oxaliplatin (O) and Metronomic Capecitabine (xeloda; X) in combination with UGT1A1-directed dosing of Irinotecan (IRI). |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The patient must meet all of the inclusion criteria to participate in the study.
- Aged above 21
- Histopathological diagnosis of pancreatic cancer
- Advanced disease not amenable to curative resection (locally advanced or metastatic disease)
- Measureable disease by RECIST 1.1 criteria
Key exclusion criteria (10 listed)
- Any patient meeting any of the exclusion criteria at baseline will be excluded from participation.
- History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free after definitive primary treatment for at least 5 years.
- Untreated CNS metastases or leptomeningeal disease. Patients with brain metastases that have been treated, and are asymptomatic, and have been stable for 3 or more months after treatment are allowed. A baseline CT or MRI brain is only required if there is clinical suspicion of CNS involvement.
- Concurrent illness, including severe infection, that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
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 |
|---|---|---|
| Low Dose OXIRI (LD-OXIRI)The LD-OXIRI regimen will be administered in the following sequence: * metronomic capecitabine (Xeloda; X) 650mg/m2 will administered twice a day on a daily a continuous basis; * intravenous metronomic oxaliplatin (O) 50 mg/m2 will be infused over 120 minutes on days 1 and 8 of a 21 day-cycle; followed by * intravenous irinotecan (I) will be infused over 90 minutes on days 1 and 8 of a 21 day-cycle. The dose of irinotecan will be based on the particular patient's UGT1A1*6 and UGT1A1*28 genotype status. | Drug | Low Dose OXIRI (LD-OXIRI) |
Primary outcome
Overall Response Rate (ORR).
Time frame: Up to 3 years.
The proportion of patients who have a partial or complete response as specified in RECIST 1.1.
Clinical Benefit Rate (CBR).
Time frame: Up to 3 years.
The percentage of advanced cancer patients who achieve complete response, partial response, or at least six months of stable disease as specified in RECIST 1.1.
The Grade 3-5 Toxicity Rate.
Time frame: Up to 3 years.
The proportion of patients who have adverse event(s) with Grade 3-5 toxicity as defined in CTCAE 5.0.
7 secondary outcomes
Maximum plasma concentration [(Cmax)] of low dose Capecitabine and its intermediary metabolites (5'-deoxy-5-fluorocytidine [DFCR] and 5'- deoxy-5-fluorouridine [DFUR]) and 5FU.
Time frame: At predose, 1 hr, end of irinotecan infusion on Cycle 1 Day 1 (each cycle is 21 days)
Trough concentration of low dose capecitabine and its intermediary metabolites and 5FU.
Time frame: At predose of Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 21 days)
Immunophenotyping from extracted peripheral blood mononuclear cells (PBMCs) - measurement of cytokine and chemokine concentrations in picograms per milliliters using multiplex flow cytometry.
Time frame: Up to 3 years.
Genomic analysis of circulating tumour DNA (ctDNA).
Time frame: Up to 3 years.
Identification of exosomal proteins secreted by extracellular vesicles from plasma.
Time frame: Up to 3 years.
Progression-free survival (PFS).
Time frame: Up to 3 years.
Overall survival (OS).
Time frame: Up to 3 years.
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 23 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Dr Joycelyn LEE, MBBS, MRCP (UK), M Med principal investigator
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low Dose OXIRI (LD-OXIRI) in people with Metastatic Pancreatic Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
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 11 inclusion and 10 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 23 Jun 2026. 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 Singapore. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Dr Joycelyn LEE, MBBS, MRCP (UK), M Med (+65 64368000, joycelyn.lee.j.x@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR). (time frame: Up to 3 years.). The study lists 3 primary outcomes in all. 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 23 Jun 2026.