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NOT YET RECRUITING
NCT07095309
PHASE2

Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/ III Colorectal Cancer

Sponsor: Metanoic Health Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

Artesunate

Artesunate 200mg PO OD for 14 days prior to colorectal resection surgery

DRUG

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