Cervical cancer
Conditions
Interventions
observed group:Cadonilimab with chemoradiotherapy
Sponsors
Tianjin Cancer Hospital Airport Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects are able to understand and voluntarily sign a written informed consent. The informed consent must be signed before the specified research procedures required by the study are performed. 2. Aged >= 18 years old and female on the day of signing the informed consent. 3. Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1. 4. Expected survival period is >= 6 months. 5. Cervical cancer confirmed by histology or cytology. 5.1 Pathological type is squamous cell carcinoma; 5.2 No anti-tumor treatment (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy and immunotherapy) has been received. Note: Pelvic lymph node or para-aortic lymph node resection or biopsy for the purpose of clinical staging is allowed. 5.3 FIGO2018 stage is ?A-?A. If diagnosed with stage ?C1, there must be >=2 confirmed metastatic lymph nodes. Lymph node metastasis can be diagnosed by biopsy or imaging; imaging diagnosis of lymph node metastasis must meet any of the following criteria: MRI or CT shows positive lymph nodes (minimum transverse diameter >= 10mm), and it should be noted that the minimum transverse diameter must be >= 15mm to be used as a target lesion. 18F-FDG PET/CT indicates positive lymph nodes (SUVmax >= 2.5) 6. At least one measurable tumor lesion according to RECIST v1.1 standards. 7. All subjects must be willing to provide tumor tissue samples before randomization. 8. Good organ function: 8.1 Hematology (no blood components and cell growth factor support therapy were used within 7 days before the start of study treatment): absolute neutrophil ANC >= 1.5 × 10^9/L (1,500/mm^3); platelet count >= 100 × 10^9/L (100,000/mm^3); hemoglobin >= 90 g/L. 8.2 Kidney: Calculated creatinine clearance* (CrCl) >= 50 mL/min. * CrCl will be calculated using the Cockcroft-Gault formula (Cockcroft-Gault formula) CrCl (mL/min) = {(140 - age) × body weight (kg) × 0.85}/ (serum creatinine. (mg/dL) × 72). Urine protein = 28 g/L 8.4 Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) = 50%. 9. Female subjects of childbearing potential must undergo a urine or serum pregnancy test within 3 days before the first medication (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required, and the serum pregnancy result shall prevail), and the result must be negative. If a female subject of childbearing potential has sexual intercourse with a male partner who is not sterilized, the subject must use an acceptable contraceptive method from the start of screening and must agree to continue using the contraceptive method within 120 days after the last dose of the study drug; whether to stop contraception after this time point should be discussed with the investigator. Cyclic abstinence and safe period contraception are unacceptable contraceptive methods. Women of childbearing potential refer to those who have not undergone surgical sterilization (i.e. bilateral tubal ligation, bilateral
Exclusion criteria
Exclusion criteria: 1. Subjects with other pathological histological types of cervical cancer, such as neuroendocrine carcinoma, sarcoma, etc. 2. Evidence of distant metastasis, including inguinal lymph node metastasis and lymph node metastasis above the level of the upper edge of the proximal L1 vertebra. 3. A total hysterectomy (resection of the uterine body + cervix) was performed. A history of surgery to preserve the cervix, such as subtotal hysterectomy or uterine angle resection, is allowed. 4. Brachytherapy cannot be used due to anatomical abnormalities and other reasons. 5. MRI imaging cannot be performed with an indwelling metal intrauterine device. 6. Suffering from other active malignant tumors within 2 years before randomization, except for locally curable tumors that appear to have been cured, such as squamous cell carcinoma of the skin, basal cell carcinoma of the skin, superficial bladder cancer, and breast carcinoma in situ. 7. There is clinically significant bilateral hydronephrosis, which cannot be relieved by nephrostomy or ureteral stent placement as determined by the investigator. 8. Subjects who have received any treatment targeting tumor immune mechanisms, such as immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) or immune co-stimulatory factors (such as antibodies targeting ICOS, CD40, CD137, GITR, OX40 targets, etc.). 9. Subjects who need systemic treatment with glucocorticoids (> 10 mg/day prednisone or equivalent dose of glucocorticoids) or other immunosuppressive drugs within 2 weeks before randomization; except for the following: a) Inhaled, ophthalmic or topical glucocorticoid treatment with a dose of <= 10 mg/day prednisone or equivalent dose is allowed. b) Physiological glucocorticoid replacement therapy, with a dose of <= 10 mg/day prednisone or equivalent dose of glucocorticoids. c) Glucocorticoids as a preventive medication for hypersensitivity reactions (such as medication before CT examination). Received immunomodulatory drugs (such as thymosin, interferon, interleukin-2) within 2 weeks before randomization 10. Received immunomodulatory drugs (such as thymosin, interferon, interleukin-2) within 2 weeks before randomization. 11. Active infection requiring systemic treatment (including active pulmonary tuberculosis, active syphilis spirochete infection and fungal infection requiring systemic treatment), note: antiviral drugs used for hepatitis B virus are excluded. 12. Severe infection within 4 weeks before randomization, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia. 13. Received major surgical treatment (determined by the investigator), open biopsy or significant trauma within 4 weeks before randomization; or required elective major surgical treatment during the study. Systematic pelvic/para-aortic lymphadenectomy for diagnostic purposes is allowed. 14. Used live vaccines within 4 weeks before randomization. 15. Patients with active or recurrent autoimmune diseases, except for the following: vitiligo, alopecia, psoriasis or eczema that do not require systemic treatment; hypothyroidism caused by autoimmune thyroiditis that only requires a stable dose of hormone replacement therapy; type I diabetes that only requires a stable dose of insulin replacement therapy. Any of the following cardiovascular and cerebrovascular diseases: a) Hypertension that cannot be controlled despite adequate antihypertensive drug tre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year progression-free survival rate;progression-free survival ;Objective response rate;Disease control rate;Duration of Response;Time to response;Overall survival;3-year overall survival rate;5-year overall survival rate; | — |
Countries
China
Contacts
Public ContactChen Zhongjie
Tianjin Cancer Hospital Airport Hospital
Outcome results
None listed