Safety and Efficacy of Oral Artesunate for Pre-cervical Cancer (NCT07095478) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Safety and Efficacy of Oral Artesunate for Pre-cervical Cancer
Malaysia28 participantsStarted 2025-08-01
Plain-language summary
NeoART-CIN is a Phase II clinical study evaluating the safety and effectiveness of oral artesunate in patients with pre-cancerous cervical intra-epithelial neoplasia (CIN2/3), to investigate if a course of treatment with oral artesunate can reverse pre-cancerous changes in the cervix and prevent the development and progression of invasive cancer. Findings from this study will increase our understanding of the effects of artesunate on CIN2/3 and if confirmatory inform future clinical studies.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18 or over
* Histologically proven HPV positive cervical CIN2/3
* WHO performance status 0-2
* 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
* Adequate hepatobiliary function:
* Total bilirubin \< 3 x Upper limit normal
* Female participants of child bearing 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 intervention
* Patient able and willing to provide written, informed consent for the study
Exclusion Criteria:
* • Contraindication to the use of artesunate due to hypersensitivity
* Pregnancy or lactation
* Weight \< 52 kg
* History of previous CIN
* Immunocompromised patients
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Histological regression of CIN2/3 on colposcopy and biopsy at Day 90
Timeframe: From enrolment to end of trial at Day 90