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Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/ III Colorectal Cancer
Sponsor: Metanoic Health Ltd.
Summary
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.
Official title: Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-08-15
Completion Date
2033-07-31
Last Updated
2025-07-31
Healthy Volunteers
No
Conditions
Interventions
Artesunate
Artesunate 200mg PO OD for 14 days prior to colorectal resection surgery
Artesunate matching Placebo
Matched placebo PO OD for 14 days prior to colorectal resection surgery
Locations (6)
Hospital Sultanah Bahiyah
Alor Star, Kedah, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
Pusat Perubatan Universiti Malaya
Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Umum Sarawak
Kuching, Sarawak, Malaysia
Hospital Sungai Buloh
Sungai Buloh, Selangor, Malaysia
Hospital Pulau Pinang
Pulau Pinang, Malaysia