Evaluating pre-operative artesunate for colorectal cancer
Official title: Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer
Run by St George's, University of London · NCT02633098 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing whether taking an antimalarial drug called artesunate for two weeks before surgery can help prevent cancer from coming back in people with Stage II/III colorectal cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | St George's, University of London Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Gillingham, Kent and 7 other locations) |
| Trial ID | NCT02633098 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 or older with Stage II/III colorectal cancer who are scheduled for surgical resection and do not require neoadjuvant chemotherapy.
✕Probably not a fit
Patients with advanced colorectal cancer requiring immediate chemotherapy or those with significant comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study assesses the safety and effectiveness of administering artesunate, an antimalarial drug, orally for 14 days before surgery in patients with Stage II/III colorectal cancer. Two hundred patients will be randomly assigned to receive either artesunate or a placebo, with the aim of determining if this treatment can reduce cancer recurrence after surgery. The study will monitor participants for five years to evaluate long-term outcomes. The approach leverages artesunate's established safety profile and potential anticancer properties, which have shown promise in laboratory settings.
Why it matters
Potential benefit: If successful, this treatment could provide a well-tolerated and affordable option to reduce cancer recurrence in colorectal cancer patients undergoing surgery.
How similar studies have gone: While some laboratory studies have indicated the potential of artesunate in cancer treatment, this specific approach in a clinical setting is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria 1. Aged 18 or over 2. Histologically proven single primary site colorectal adenocarcinoma or high grade dysplasia plus unequivocal radiological evidence of invasive cancer 3. Stage II/III colorectal cancer planned for surgical resection and no clinical indication for neoadjuvant preoperative chemotherapy/chemoradiation therapy 4. WHO performance status 0,1 or 2 5. Adequate full blood count: White Cell Count (WCC) \>3.0 x 10\^9 /l; Platelets \>100 x 10\^9/l; Haemoglobin (Hb) \>80g/L 6. Adequate renal function: Glomerular Filtration Rate \>30ml/min by Cockcroft-Gault formula 7. Adequate hepatobiliary function : Bilirubin \< 3 x Upper limit normal 8. Female participants of child bearing potential must have a negative pregnancy test \< 72 hours prior to initiating study intervention and agree to avoid pregnancy using adequate, medically approved contraceptive precautions for up to 6 weeks after the last dose of study treatment intervention 9. Male participants with a partner of childbearing potential must agree to use adequate, medically approved contraceptive precautions during and for up to 6 weeks after the last dose of the study treatment intervention 10. Patient able and willing to provide written, informed consent for the study. Exclusion criteria 1. Contraindication to the use of artesunate due to hypersensitivity 2. Pregnancy or lactation 3. Male or female participants unwilling to use an effective method of birth control (either hormonal in the form of contraceptive pill or barrier method of birth control accompanied by the use of a proprietary spermicidal foam/gel or film); or agreement of true abstinence from time to consent is signed until 6 weeks after the last dose of study treatment intervention (i.e. withdrawal, calendar, ovulation, symptothermal and post ovulation methods are not considered acceptable methods) 4. History of immunosuppression 5. History of hearing or balance problems 6. Weight \< 52kg or \> 110kg 7. Other planned intervention, apart from standard of care 8. Any other malignant disease diagnosis within the preceding 2 years with the exception of non-melanomatous skin cancer and carcinoma in situ 9. Lactose intolerance
Where it's running
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Barking, Havering and Redbridge University Hospitals NHS Trust
Barking, United Kingdom Recruiting -
Ashford & St Peters Hospital NHS Foundation Trust
Chertsey, United Kingdom Recruiting -
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, United Kingdom Recruiting -
Norfolk & Norwich University Hospitlas NHS FT
Norwich, United Kingdom Recruiting -
Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, United Kingdom Recruiting -
Medway Maritime Hospital
Gillingham, Kent, United Kingdom Completed
Show 2 more locations
-
Kent Oncology Centre, Maidstone Hospital
Maidstone, Kent, United Kingdom Completed -
St George's University Hospitals NHS Fundation Trust
London, United Kingdom Active not recruiting
Study contacts
- Principal investigator: Professor Sanjeev Krishna, BMBCh, DPhil, ScD — St George's University Hospitals NHS Foundation Trust
- Study coordinator: Professor Sanjeev Krishna, FRCP, ScD, FMedSci
- Email: s.krishna@sgul.ac.uk
- Phone: ++44(0)208 725 5836
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.