Actively Recruiting
Metronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients
Led by National Cancer Centre, Singapore · Updated on 2025-06-11
50
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
N
National Cancer Centre, Singapore
Lead Sponsor
N
National Medical Research Council (NMRC), Singapore
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Metronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged above 21 years
- Histopathological diagnosis of pancreatic cancer
- Advanced disease not suitable for curative surgery (locally advanced or metastatic)
- Measurable disease by RECIST 1.1 criteria
- Life expectancy of at least 12 weeks
- ECOG performance status between 0 and 2
- Adequate blood cell counts (granulocytes ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L)
- Adequate liver function (total bilirubin ≤ 1.5 times upper limit of normal, AST, ALT, ALP ≤ 3 times upper limit or < 5 times if liver involved)
- Adequate kidney function (creatinine clearance > 50 mL/min)
- Able to provide written informed consent
You will not qualify if you...
- History of another cancer within 5 years except certain treated skin and bladder cancers
- Untreated brain or leptomeningeal metastases; treated and stable brain metastases allowed
- Severe infections or illnesses that may risk safety or study compliance
- Serious medical or psychiatric conditions limiting protocol compliance
- Palliative chemotherapy or radiotherapy within 4 weeks before enrollment
- Major surgery within 2 weeks before enrollment
- Chronic immunosuppressive therapy
- Pregnancy, breastfeeding, or inadequate contraception
- Use of anticoagulant therapy with vitamin K antagonists
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Centre, Singapore
Singapore, Singapore, 168583
Actively Recruiting
Research Team
D
Dr Joycelyn LEE, MBBS, MRCP (UK), M Med
CONTACT
T
Tze Wei LIM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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