Cervical cancer
Conditions
Interventions
Treatment group:Zimberelimab combine with chemoradiotherapy
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Female, =18 years old. 2.Histologically/cytologically confirmed advanced-stage cervical cancer, including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. 3.Patients diagnosed with advanced-stage cervical cancer (with high-risk factors) confirmed by pathology or clinical diagnosis according to the International Federation of Gynecology and Obstetrics (FIGO) 2018 staging system (stage III-IVB), and meeting at least one of the following conditions: A. Tumor lesion size =5cm; B. Lymph node metastasis: Pelvic cavity: MRI or CT shows 2 or more positive pelvic lymph nodes (minimum diameter = 1.5 cm); Retroperitoneal: MRI or CT shows one or more positive para aortic lymph nodes (minimum diameter = 1.5 cm); C. At least one measurable lesion at baseline (stage IVA-IVB), complies with RECIST 1.1 target lesion standards. Tumor evaluation must be conducted through CT scan or MRI within 28 days; D. If the patient is at stage IVB, they should be potentially curable through radiotherap, such as inguinal lymph node metastasis and/or supraclavicular lymph node metastasis. 4.No prior radical surgical intervention, radiotherapy, or systemic treatment (including investigational drugs) for cervical cancer and no previous immunotherapy. 5.Participants must have sufficient organ function, defined as follows: -Hemoglobin = 9.0 g/dL -Absolute neutrophil count = 1.5 × 10 ^ 9/L -Platelet count = 75 × 10 ^ 9/L -Serum bilirubin = 1.5 x Upper limit of normal value (ULN) -Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 × ULN -The creatinine clearance rate (CrCl) should be = 60mL/min, calculated using the CockcroftGault formula (using actual body weight) or determined by collecting 24-hour urine. Female: creatinine CL=body weight (kg) x(140 years old) x 0.85 (mL/min) 72 x serum creatinine (mg/dL) 6. Female participants tested negative for serum pregnancy test within 72 hours prior to receiving study treatment (if there is fertility potential) and agreed to contraception 150 days after the last dose of study treatment, or did not have fertility potential. Male partners must agree to use appropriate contraceptive methods from the start of the first dose of study treatment until 150 days after the last dose of study treatment. 7. Participants must agree not to breastfeed during the study period or for 150 days after the last treatment. 8. Participants must be able to understand the research procedure and agree to participate in the study by providing written informed consent. 9. ECOG score 0-1. 10. Life expectancy = 3 months.
Exclusion criteria
Exclusion criteria: 1.Histological types not included in the inclusion criteria, such as sarcoma, small cell carcinoma with neuroendocrine differentiation, and non epithelial carcinoma;. 2.History of prior hysterectomy (defined as removal of the entire uterus), or will undergo hysterectomy as part of the initial treatment for cervical cancer. Attention: Women who undergo partial/subtotal hysterectomy for reasons other than cervical cancer are eligible to participate in this study. 3.Bilateral hydronephrosis, unless at least one side has a stent implanted or resolved through percutaneous nephrostomy, or considered mild and clinically insignificant at the discretion of the investigator. 4.Any reason or contraindication that prevents the use of intracavitary brachytherapy alone or in combination with intracavitary and interstitial brachytherapy. 5.Patients with severe active autoimmune diseases who require glucocorticoid or systemic immunosuppressive therapy within 2 years prior to first administration. Patients whose diseases have been controlled and do not need systemic immunosuppressive treatment are allowed to be included in the group, such as type I diabetes, hypothyroidism that only needs hormone replacement treatment, and skin diseases that do not need systemic treatment (such as vitiligo, psoriasis, and alopecia). 6.Presence of liver, lung, or other visceral organ metastases at stage IVB. 7.Presence of an infectious disease requiring systemic antimicrobial therapy (excluding hepatitis B virus infection) within 14 days prior to first dose administration. 8.Breastfeeding or pregnant women. 9.Prior treatment with anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, or anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibodies. 10. It is known that the subject has previously been allergic to macromolecular protein formulations/monoclonal antibodies, or is known to be allergic to any component of the investigational drug; 11. Individuals who need to receive systemic corticosteroids (with a dose equivalent to or higher than 10 mg/day of prednisone) or other immunosuppressive drugs within 14 days prior to enrollment or during the study period; 12. Those who have received live vaccination within 4 weeks before the start of treatment; 13. Those who have received anti-tumor vaccines or received anti-tumor treatments with systemic immune stimulation; 14. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 15. Have a history of alcoholism, drug abuse, or drug abuse within the past year; 16. Individuals with a clear history of neurological or psychiatric disorders, such as epilepsy, dementia, and poor compliance; 17. Other severe, acute, or chronic diseases or laboratory abnormalities that may increase the risk of participating in research and drug use, or may interfere with the interpretation of research results; 18. Participants have severe, uncontrolled diseases or non malignant systemic diseases. For example: uncontrolled ventricular arrhythmias, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizures, unstable spinal cord compression, superior vena cava syndrome; 19. Participants have a known history of human immunodeficiency virus. 20. The presence of other serious physical or mental illnesses or laboratory test abnormalities may increase the risk of participating in the study, affect study compliance, o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR(Objective response rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR(Duration of remission);DCR(Disease control rate);PFS(Progression-free survival);OS(Overall survival);Safety; | — |
Countries
China
Contacts
Public ContactZhang Yunyan
Harbin Medical University Cancer Hospital
Outcome results
None listed