Locally advanced cervical cancer
Conditions
Interventions
Standard concurrent chemoradiotherapy group:NA
Sponsors
Tianjin Medical University Cancer Institute & Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18–75 years; 2. Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma based on biopsy specimens reviewed by experienced pathologists; 3. Locally advanced cervical cancer (LACC) staged IB2, IB3, II, III, or IVA according to the 2018 International Federation of Gynecology and Obstetrics (FIGO) staging system, with staging confirmed by clinical examination and imaging studies, including pelvic magnetic resonance imaging (MRI) and/or positron emission tomography–computed tomography (PET-CT); 4. Baseline confirmation of high-risk HPV infection (types 16 or 18) by quantitative HPV DNA testing; 5. Planned to receive, and medically able to tolerate, definitive concurrent chemoradiotherapy (CCRT) with curative intent; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0–1; 7. Adequate bone marrow, hepatic, and renal function to meet treatment requirements; 8. Estimated life expectancy of at least 6 months; 9. Ability to understand the study requirements, comply with the study protocol and follow-up schedule, and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. female patients aged 18–75 years; 2. histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma based on biopsy specimens reviewed by experienced pathologists; 3. LACC staged as International Federation of Gynecology and Obstetrics (FIGO) 2018 classification stage IB2, IB3, II, III, or IVA, confirmed by clinical examination and imaging studies including pelvic magnetic resonance imaging (MRI) and/or positron emission tomography-computed tomography (PET-CT); 4. baseline confirmation of high-risk HPV infection (types 16 and 18) by quantitative HPV DNA testing performed on cervical tissue or liquid-based cytology samples using polymerase chain reaction (PCR)-based assays; 5. planned to receive and medically able to complete definitive CCRT with curative intent; 6. Eastern Cooperative Oncology Group (ECOG) performance status 0–1; 7. adequate bone marrow function (white blood cell count >=3.0×10?/L, absolute neutrophil count >=1.5×10?/L, platelet count >=100×10?/L, hemoglobin >=90 g/L), adequate hepatic function (total bilirubin =60 mL/min); 8. estimated life expectancy =6 months; 9. ability to comply with the study protocol and scheduled follow-up visits; 10. provision of written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Objective response rate (ORR);Dynamic changes in plasma HPV ctDNA levels;Predictive performance of HPV ctDNA for disease recurrence;Concordance between ctDNA and imaging; | — |
Countries
China
Contacts
Public ContactHou Hailing
Tianjin Medical University Cancer Institute & Hospital
Outcome results
None listed