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NCT05764044: AddChemo
Adjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer
Phase 3 trial testing cisplatin, gemcitabine in Cervical Cancer in 365 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Hospital do Coracao |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 365 |
| Start date | 27 March 2024 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 26 locations across Brazil |
Drugs / interventions tested
- cisplatin, gemcitabine
- Follow-up
Conditions studied
- Cervical Cancer — all drugs for Cervical Cancer →
- Cervix Cancer — all drugs for Cervix Cancer →
- Cervix Neoplasm — all drugs for Cervix Neoplasm →
Sponsor
Hospital do Coracao
Who can join
Adults 18 to 70, female only, with Cervical Cancer or Cervix Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study hypothesizes that patients who persist with cell-free human papillomavirus deoxyribonucleic acid (cfHPV-DNA) plasma expression at the end of standard treatment, can derive the benefit of using adjuvant chemotherapy in locally advanced cervical cancer (CC). After standard treatment based on concomitant chemoradiotherapy regime, a qualitative and quantitative research of cfHPV-DNA in plasma of patients will be conducted. Patients who have positive research for plasma cfHPV-DNA at the end of chemoradiotherapy treatment will be randomized to receive two additional cycles of adjuvant chemotherapy or observation. Patients will be followed with conduction of computed tomography (CT) scan of the thorax and magnetic resonance (MRI) of abdomen and pelvis and clinical and gynecological examination at every four months.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Viral oncogenesis in cancer: from mechanisms to therapeutics.
Xiao Q, Liu Y, Li T, Wang C, et al · · 2025 · cited 45× · PMID 40350456 · DOI 10.1038/s41392-025-02197-9
Verify or expand the search:
- PubMed search for NCT05764044
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cervical Cancer
Currently open trials in the same condition.
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- NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
- NCT07209917 — Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India · NA · recruiting
- NCT07256236 — SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer · Phase 2 · recruiting
Other Hospital do Coracao trials
Trials by the same sponsor.
- NCT07534163 — III Brazilian Registry of Heart Failure · not yet recruiting
- NCT07129733 — Oral Care Layered Enhancement for Improved Oral Hygiene in Intensive Care Units · NA · not yet recruiting
- NCT07037524 — Low Dose Radiotherapy for Heart Failure · Phase 1, PHASE2 · not yet recruiting
- NCT06546137 — National Network for Cardiovascular Genomics: Advancing Cardiovascular Healthcare for Hereditary Diseases in Brazil's Un · recruiting
- NCT06547892 — Use of Vasopressin in Patients at High Risk of Acute Kidney Injury Admitted to the ICU · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05764044 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital do Coracao
- Last refreshed: 30 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05764044.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing