OncoMatch/Clinical Trials/NCT05764044
Adjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer
Is NCT05764044 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies cisplatin, gemcitabine for cervical cancer.
Treatment: cisplatin, gemcitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cervical Cancer
Disease stage
Required: Stage IIA, IIB, IIIA, IIIB, IIIC1, IIIC2, IVA (FIGO 2018)
International Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB3 to IVA
Prior therapy
Must have received: concomitant chemoradiotherapy (cisplatin) — definitive
Previous standard treatment based on concomitant chemoradiotherapy regimen
Cannot have received: any prior malignancy
Previous cervical cancer or other malignancies
Lab requirements
Blood counts
absolute neutrophils count 1.5 x 10^9/L, platelets 100 x 10/L
Kidney function
calculated creatinine clearance 50 mL/min
Liver function
serum bilirubin 2.0 x upper limit of normal (ULN), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase 2.5 x ULN
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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