NCT07095309Not yet recruitingPhase 2
Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/ III Colorectal Cancer
Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 7 Jul 2025
- Start date
- 15 Aug 2025
- Primary completion date
- 30 Aug 2032
- Lead sponsor
- Metanoic Health Ltd.
- Diseases
- Colorectal cancer
- NCT number
- NCT07095309
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 15 Aug 2025 to the primary completion date, 30 Aug 2032
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Sultanah Bahiyah Coordinator of this site? Confirm its status | Alor Star | Malaysia | Unknown status |
| Pusat Perubatan Universiti Malaya Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Hospital Kuala Lumpur Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Hospital Umum Sarawak Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
| Hospital Pulau Pinang Coordinator of this site? Confirm its status | Pulau Pinang | Malaysia | Unknown status |
| Hospital Sungai Buloh Coordinator of this site? Confirm its status | Sungai Buloh | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.