Tests artesunate before surgery in people with colorectal cancer
Tests artesunate or a placebo before surgery in adults with colorectal cancer.
Plain-language title generated from the registry record
Registry title: Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/ III Colorectal Cancer
Key facts
- Where
- Alor Star, Kuala Lumpur, Kuching, Pulau Pinang, and Sungai Buloh, MalaysiaSee the 6 sites
- Phase
- Phase 2
Where in Malaysia
- Hospital Sultanah BahiyahAlor Star, MalaysiaNo longer taking part
- Hospital Kuala LumpurKuala Lumpur, MalaysiaNo longer taking part
- Pusat Perubatan Universiti MalayaKuala Lumpur, MalaysiaNo longer taking part
- Hospital Umum SarawakKuching, MalaysiaNo longer taking part
- Hospital Pulau PinangPulau Pinang, MalaysiaNo longer taking part
- Hospital Sungai BulohSungai Buloh, MalaysiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Metanoic Health Ltd.
- Trial code
- NCT07095309
- Record updated
- 31 July 2025
- Original description
TThis study evaluates the safety and effectiveness of pre-operative artesunate, given orally once a day for 14 days prior to surgery, in patients with Stage II/III colorectal cancer.Read full original descriptionShow less
Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer
TThis study evaluates the safety and effectiveness of pre-operative artesunate, given orally once a day for 14 days prior to surgery, in patients with Stage II/III colorectal cancer.
Artesunate is an established antimalarial drug with an excellent safety profile. It is well tolerated, affordable, and widely available. Several laboratory studies and one small pilot clinical study in patients with colorectal cancer have shown that artesunate can reduce the proliferation and growth of cancer cells.
One hundred patients diagnosed with Stage II/III operable colorectal cancer will be randomly allocated to receive oral artesunate 200 mg daily or a matching placebo for 14 days prior to surgery. Patients will then be followed closely for 5 years to determine whether pre-operative artesunate reduces the risk of cancer recurrence after surgery.
Inclusion: Aged 18 or over; Histologically proven single primary site colorectal adenocarcinoma or high grade dysplasia plus unequivocal radiological evidence of invasive cancer; Stage II/III colorectal cancer planned for surgical resection and no clinical indication for neoadjuvant preoperative chemotherapy/chemoradiation therapy; WHO performance status 0,1 or 2; Adequate full blood count: White Cell Count (WCC) >3.0 x 109 /l; Platelets >100 x 109/l; Haemoglobin (Hb) >80g/L; Adequate renal function : Glomerular Filtration Rate >30ml/min by Cockcroft-Gault formula; Adequate hepatobiliary function : Total bilirubin < 3 x Upper limit norm; Female participants of childbearing 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 interventions; 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; Patient able and willing to provide written, informed consent for the study.
Exclusion: Contraindication to use of artesunate due to hypersensitivity; History of hearing or balance problems; History of immunosuppression; Any other malignant disease diagnosis within the preceding 2 years with the exception of non-melanomatous skin cancer and carcinoma in situ; Pregnancy or lactation; Male or female participants unwilling to use an effective method of birth control (either hormonal in the form of the 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 consent is signed until 6 weeks after the last dose of study treatment intervention (i.e. withdrawal, calendar, ovulation, symptothermal and post ovulation are not acceptable methods); Patient weight < 52 kg or > 110 kg; Other planned intervention, apart from standard of care; Lactose intolerance.