A Clinical Study of Pelvic Concurrent Chemoradiotherapy Combined with CT-guided Intracavitary Brachytherapy with Adaptive Simultaneous Dose Escalation for Locally Advanced Cervical Cancer

Inclusion criteria

• Sign the informed consent;
• Age :18 to 75 years old;
• Histologically or cytologically confirmed cervical cancer;
• According to the International Federation of Gynecology and Obstetrics (FIGO 2018) stage IB3, IIA2, IIB, III, IV (local advanced), and had not received treatment before enrollment;
• Measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
• ECOG physical performance score 0-2;
• Expected survival time >= 3 months;
• LVEF >= 55%;
• Bone marrow function: neutrophil >= 1.5×109/L, platelet ≥ 100×109/L, white blood cell 4.0-10.0×109/L, hemoglobin >= 90 g/L;
• Liver and kidney function: serum creatinine <= 1.5 times upper limit of normal; AST and ALT≤2.5 times upper limit of normal (ULN) or <= 5 times ULN in the presence of liver metastasis; Total bilirubin <=1.5 times upper limit of normal, or <= 2.5 times upper limit of normal if the patient has Gilbert's syndrome;
• Subjects of childbearing age must agree to use effective contraception during the trial, and women of childbearing age must have a negative serum or urine pregnancy test;
• Non-lactating patients;

Exclusion criteria

• Patients with prior abdominal or pelvic radiotherapy;
• being mentally ill and unable to cooperate with treatment;
• Serious uncontrolled medical diseases, such as serious internal medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
• Unable to tolerate cisplatin chemotherapy;
• receiving other experimental drugs or participating in clinical trials for other anticancer treatment purposes within 30 days before the first radiotherapy;
• Severe infection within 4 weeks before study treatment, including but not limited to infectious complications requiring hospitalization, bacteremia, or severe pneumonia;
• Human immunodeficiency virus (HIV) -positive persons;
• HBsAg positive and HBV-DNA titer >= 1×10^3 IU/mL; Participants were eligible for inclusion if they were HBsAg positive and had a peripheral blood HBV-DNA level of < 1×10^3 IU/mL, and if the investigator considered the participant to be in a stable phase of chronic hepatitis B without increasing the risk to the participant.
• Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive and HCV RNA test positive;
• Patients judged by the investigator to be ineligible for the study.