Clinical trial · Interventional
Safety and Efficacy of Oral Artesunate for Pre-cervical Cancer
Phase II Single Arm, Open Label Study of Artesunate for the Treatment of Human Papilloma Virus Positive High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
NCT07095478CI-TRIAL-00092919NeoART-CINnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CIN 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artesunate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Artesunate
- description
- 200mg oral tablets once daily for 14 days, with 7 days break for 3 cycles.
- interventionNames
- Drug: Artesunate
Primary outcomes (1)
- measure
- Histological regression of CIN2/3 on colposcopy and biopsy at Day 90
- timeFrame
- From enrolment to end of trial at Day 90
- description
- Histological regression will be defined as histologic regression to CIN1 or less.
Secondary outcomes (12)
- measure
- HPV DNA viral clearance at Day 90.
- timeFrame
- Measured at the end of the trial at Day 90
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDLiu Z, Zhang J, Li S, Jiang J. Artesunate Inhibits Renal Ischemia Reperfusion-Stimulated Lung Inflammation in Rats by Activating HO-1 Pathway. Inflammation. 2018 Feb;41(1):114-121. doi: 10.1007/s10753-017-0669-3. PMID 28921399
- BACKGROUNDKrishna S, Bustamante L, Haynes RK, Staines HM. Artemisinins: their growing importance in medicine. Trends Pharmacol Sci. 2008 Oct;29(10):520-7. doi: 10.1016/j.tips.2008.07.004. Epub 2008 Aug 25. PMID 18752857
- BACKGROUNDKay J, Thadhani E, Samson L, Engelward B. Inflammation-induced DNA damage, mutations and cancer. DNA Repair (Amst). 2019 Nov;83:102673. doi: 10.1016/j.dnarep.2019.102673. Epub 2019 Jul 25. PMID 31387777
- BACKGROUNDJansen FH, Adoubi I, J C KC, DE Cnodder T, Jansen N, Tschulakow A, Efferth T. First study of oral Artenimol-R in advanced cervical cancer: clinical benefit, tolerability and tumor markers. Anticancer Res. 2011 Dec;31(12):4417-22. PMID 22199309
- BACKGROUNDHo WE, Peh HY, Chan TK, Wong WS. Artemisinins: pharmacological actions beyond anti-malarial. Pharmacol Ther. 2014 Apr;142(1):126-39. doi: 10.1016/j.pharmthera.2013.12.001. Epub 2013 Dec 6. PMID 24316259
- BACKGROUNDHeinonen A, Gissler M, Riska A, Paavonen J, Tapper AM, Jakobsson M. Loop electrosurgical excision procedure and the risk for preterm delivery. Obstet Gynecol. 2013 May;121(5):1063-1068. doi: 10.1097/AOG.0b013e31828caa31. PMID 23635744
- BACKGROUNDHanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell. 2011 Mar 4;144(5):646-74. doi: 10.1016/j.cell.2011.02.013. PMID 21376230
- BACKGROUNDBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.