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

NCT07095309 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-31

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Clinical Research Malaysia

    collaborator UNKNOWN

  • Metanoic Health Ltd.

    lead INDUSTRY

Principal Investigators

  • Emeritus Professor Sanjeev Krishna, FRCP, ScD, FMedSci · Centre for Affordable Diagnotics and Therapeutics

  • Dr Yolanda Augustin · Centre for Affordable Diagnotics and Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2032-08-30
Completion
2033-07-31

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07095309 on ClinicalTrials.gov