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Using adjuvant chemotherapy for cervical cancer patients with positive HPV DNA in plasma

Adjuvant Chemotherapy in Cell-free Human Papillomavirus Deoxyribonucleic Acid (cfHPV-DNA) Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer (CC)

PHASE3 · Hospital do Coracao · NCT05764044

This study is testing if adding extra chemotherapy can help women with advanced cervical cancer who still have HPV DNA in their blood after standard treatment.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment365 (estimated)
Ages18 Years to 70 Years
SexFemale
SponsorHospital do Coracao (other)
Drugs / interventionschemotherapy, radiation
Locations26 sites (Manaus, Amazonas and 25 other locations)
Trial IDNCT05764044 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of adjuvant chemotherapy in patients with locally advanced cervical cancer who test positive for cell-free human papillomavirus (cfHPV-DNA) in their plasma after standard treatment. Following a regimen of chemoradiotherapy, patients will undergo testing for cfHPV-DNA, and those who remain positive will be randomized to receive either two additional cycles of chemotherapy or be placed under observation. The study aims to determine if the addition of chemotherapy can improve outcomes for these patients. Participants will be monitored through imaging and clinical examinations every four months.

Who should consider this trial

Good fit: Ideal candidates include women with FIGO stage IB3 to IVA cervical cancer who have undergone standard chemoradiotherapy and have positive cfHPV-DNA results.

Not a fit: Patients who do not have positive cfHPV-DNA results after standard treatment or those with advanced comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved survival rates and outcomes for patients with locally advanced cervical cancer who have persistent HPV DNA in their plasma.

How similar studies have performed: Other studies have shown promising results with similar biomarker-driven approaches in cancer treatment, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* International Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB3 to IVA will be included prospectively.
* Previous standard treatment based on concomitant chemoradiotherapy regimen.
* Karnofsky performance status score ≥70, with estimated life expectancy ≥12 weeks,
* Immunocompetent,
* Positive research for types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 69, 73, 82 cfHPV-DNA in plasma at the end of chemoradiotherapy,
* Proper hematological, liver and kidney functions. Inclusion criteria will include absolute neutrophils count ≥1.5 x 109/L, platelets ≥100 x 10/L, serum bilirubin ≤ 2.0 x upper limit of normal (ULN), calculated creatinine clearance ≥50 mL/min and alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase ≤ 2.5 x ULN.
* Patients of child-bearing potential were obligated to use an approved contraceptive method during and for 3 months after the study;
* Agree with research procedures, by signing the Informed Consent Form (ICF).

Exclusion Criteria:

* Previous cervical cancer or other malignancies,
* Pregnant women,
* Inability to perform concurrent cisplatin based-chemoradiotherapy.
* Tumors containing different HPV genotypes
* Absence of anatomopathological examination to prove the diagnosis and/or staging examinations.

Where this trial is running

Manaus, Amazonas and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Cervical Cancer, Cervix Cancer, Cervix Neoplasm, Human papillomavirus, HPV, Cervical cancer, Circulating free DNA, Adjuvant chemotherapy

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.