locally advanced cervical cancer (stages IB3–IIA2, IIIA)
Conditions
Interventions
Experimental group:First, carry out short-course radiotherapy, and start immunotherapy combined with single-agent platinum chemotherapy within one week after completion.
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–70 years, female; 2.Pathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 3.FIGO 2018 stage IB3–IIA2 or IIIA, locally advanced, with no evidence of distant metastasis confirmed by imaging. 4.At least one measurable lesion (RECIST 1.1). 5.ECOG performance status score of 0–1. 6.Expected survival time = 12 weeks. 7.Adequate vital organ function, with laboratory findings (including hematology, hepatic and renal function) meeting protocol requirements. 8.No prior surgery, radiotherapy, or systemic anti-tumor therapy for locally advanced cervical cancer. 9.Ability to fully understand the study, voluntarily sign written informed consent, and willingness to comply with follow-up and treatment plans.
Exclusion criteria
Exclusion criteria: 1.Imaging confirmation of distant metastases or brain metastases. 2.Presence of other malignancies, or a history of other malignancies within 5 years (excluding cured cases such as basal cell carcinoma of the skin or carcinoma in situ of the cervix). 3.Pregnant or breastfeeding women, or those unwilling to take effective contraceptive measures during the trial period. 4.Prior treatment with immune checkpoint inhibitors (e.g., PD-1/PD-L1, CTLA-4, etc.). 5.Active autoimmune diseases, or conditions requiring long-term systemic immunosuppressants/corticosteroids. 6.Severe comorbidities involving the cardiovascular, respiratory, digestive, nervous, or psychiatric systems, which, in the investigator's judgment, may render the patient unable to tolerate the trial treatment. 7.Active infections, including active HBV/HCV replication or HIV infection. 8.Inability to cooperate with imaging assessments, or obvious poor compliance, making the patient unsuitable for trial participation in the investigator's opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical resection Rate;2-year EFS rate;Compliance;Incidence of Surgery-related Complications;Incidence of Treatment-Related Adverse Events;Event-Free Survival;Objective Response Rate;Optimal Pathological Response Rate; | — |
Countries
China
Contacts
Public ContactQin Qin, Cheng Wenjun
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed