cervical carcinoma
Conditions
Interventions
treatment group:tislelizumab + Cisplatin combined with radiotherapy
Control group:Cisplatin combined with radiotherapy
Sponsors
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Is female, between the age of 18 and 75; 2)Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix; 3)The International Federation of Gynecology and Obstetrics (FIGO) 2018 stage IIIC1-IVA and IVB (inguinal lymph nodes metastasis only) who have not received chemoradiation or radiation before; 4)Has radiographically evaluable disease: at least one measurable lesion with a tumor diameter =5cm and a lymph node diameter =1cm according to RECIST v1.1; 5)Has an Eastern Cooperative Oncology Group performance status = 2; 6)Life expectancy of greater than 3 months; 7)Laboratory results: neutrophil count=1.5×109/L; platelet count=75×109/L; hemoglobin=90g/L; serum creatinine = 1.5 the upper limit of normal; ALT and AST = 2.5 the upper limit of normal or = 5 the upper limit of normal in patients with liver metastases; serum total bilirubin = 1.5 the upper limit of normalserum albumin =3.0 g/dL; adequate coagulation (International Normalized Ratio or Prothrombin Time (PT) = 1.5 x ULN; 8)Has negative urine or blood HCG tests (except menopause and hysterectomy)Women of childbearing age and their partners must use effective contraceptive methods during the treatment period and for 6 months after the final dose of study treatment(include hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, bilateral tubal ligation, male sterilization, and copper intrauterine devices, avoidance of sexual behavior, etc); 9)Has no second tumor in the past 5 years, except the cured basal cell carcinoma of skin or squamous cell carcinoma of skin or carcinoma in situ of any other part; 10)Able to understand the content of this clinical research, the patient/legal agent voluntarily agreed to participate in the research and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1)Has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, hypothyroidism; patients with vitiligo; or has asthma in childhood with medical intervention after adulthood; asthma patients who require bronchodilators for medical intervention; 2)Has immunosuppressive agents or systemic hormonal therapy for immunosuppressive purposes (dose > 10 mg/day of prednisone or other therapeutic hormones) and continued to use within 2 weeks before enrollment; 3)Has any form of organ transplant, including allogeneic stem cell transplant; 4)Has a known additional malignancy besides the disease in this study within the past 5 years,except basal cell carcinoma of skin or squamous cell carcinoma; 5)Has clinical symptoms or diseases of the heart that are not well controlled, such as: NYHA class 2 or higher heart failure; unstable angina; have a myocardial infarction within 1 year; clinically significant supraventricular or ventricular arrhythmia requires treatment or intervention; echocardiography showing left ventricular ejection fraction 38.5°C within one week before the first dose(patients with fever due to tumors may be enrolled according to the investigator); 7)Has test positive for Human Immunodeficiency Virus (HIV), positive for treponema pallidum, untreated active hepatitis; 8)Has received a live vaccine within 4 weeks before the screening period; 9)Had a known history of psychotropic substance abuse, alcoholism or history of drug abuse; 10)Has pregnant or breastfeeding; 11)Has a known psychiatric disorder that would interfere with the participant's ability to understand or provide informed consent form; 12)According to the investigator, other severe, acute or chronic medical disorders or laboratory abnormalities that involve the risk associated with the study or that may interfere with the interpretation of the findings may be increased. or with other family or society factors that may affect participant safety, trial data and sample collection; 13)Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results; 14)In the judgment of the investigator make the participant inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GTV reduction%; | — |
Countries
China
Contacts
Public ContactYingchao Zhao
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed