cervical cancer
Conditions
Interventions
Research group:Eligible subjects will receive 3 cycles of cardonilizumab + albumin paclitaxel + cisplatin every 21 days: cardonilizumab 10mg/kg, D1 administration
Administration of albumin paclitaxel 260mg/m2 D1
Cisplatin was administered at 70mg/m2 D1.
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written ICF voluntarily. 2. Age >= 18 years old, =4 cm. 7. No distant metastases. 8. Had not received systemic or local anti-tumor therapy for cervical cancer, including radiotherapy, chemotherapy, immunotherapy, biologics, small molecule targeted therapy, etc., before the first medication. 9. Patients who agreed to undergo radical hysterectomy and who were judged by the investigator to have no contraindications. 10. The subject agrees to collect tumor tissue samples required during the screening period and during the study and use them in related research. 11. With good organ function: a) Hematology (no blood components and cell growth factors were used to support the treatment within 7 days prior to the start of the study) : i. Absolute value of neutrophil ANC >= 1.5 ×10^9/L (1,500/mm^3); ii. Platelet count >= 100 × 10^9/L (100,000/mm^3); iii. Hemoglobin >= 90 g/L. b) Kidney: i. Creatinine clearance * (CrCl) calculated value >= 50 mL/min * CrCl will be calculated using Cockcroft-Gault formula (Cockcroft-Gault formula) CrCl (mL/min) = {(140 - age) * 0.85} weight (kg)/(serum creatinine. (mg/dL) x 72) ii. Urinary protein = 28 g/L d) Coagulation function: i. International Standardized ratio (INR) and activated partial thromboplastin time (APTT) = 50%. 12. Female subjects with fertility must undergo urine or serum pregnancy test within 3 days before the first medication (if the urine pregnancy test result is not confirmed negative, serum pregnancy test is required, the serum pregnancy result shall prevail), and the result is negative. If a fertile female subject has sex with an unsterilized male partner, the subject must use an acceptable contraceptive method since screening and must consent to continued use of the contraceptive method for 120 days after the last dose of the study drug; Whether to stop contraception after this time point should be discussed with the investigator. Periodic abstinence and safe period contraception are unacceptable contraceptive methods. a) Fertile women are those who have not been surgically sterilized (i.e., bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy) or who have not undergone menopause (defined as at least 12 consecutive months of menopause without alternative medical reasons, with serum follicle-stimulating hormone levels within the laboratory reference range for postmenopausal women); b) A highly effective contraceptive method is one that has a very low failure rate (e.g., less than 1% per year) when used consistently and correctly. Not all contraceptive methods are effective. In addition to barrier contraception, fertile female subject
Exclusion criteria
Exclusion criteria: 1. In addition to cervical cancer, subjects had other malignant tumors within 3 years prior to enrollment. Subjects with other malignancies that have been cured by local treatment are not excluded, such as basal or skin squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the breast, etc. 2. Enroll in another clinical study at the same time, unless it is an observational, non-interventional clinical study or follow-up period of an interventional study. 3. Patients who require the preservation of reproductive function. 4. Received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks before the first dose; Received Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications within 1 week before the first dose. 5. Patients with active autoimmune disease that has required systemic treatment within the past two years (e.g., treatment with disease-modifying drugs, corticosteroids, immunosuppressants) and replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered a systemic treatment. 6. There is a history of noninfectious pneumonia or pneumonia requiring systemic glucocorticoid therapy or a current history of interstitial lung disease. 7. History of severe bleeding tendency or coagulation dysfunction. 8. Present uncontrolled co-morbidity, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorder, severe active peptic ulcer disease, or gastritis, or mental illness/social condition that would limit the subject's compliance with study requirements or affect the subject's ability to provide written informed consent. 9. Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia. Unstable angina pectinis, congestive heart failure, or vascular disease requiring hospitalization (such as aortic aneurysms requiring surgical repair or peripheral venous thrombosis), or other cardiac impairment that may affect the safety evaluation of the investigational drug (such as poorly controlled arrhythmias, myocardial infarction, or ischemia) in the 12 months prior to initial dosing; History of esophageal and gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before first administration; Any arterial thromboembolism event, NCI CTCAE 5.0 grade 3 or above venous thromboembolism, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy occurred within 6 months prior to initial administration; Acute exacerbation of chronic obstructive pulmonary disease occurred within 1 month before first administration; Present hypertension with systolic blood pressure >=160mmHg or diastolic blood pressure >=100mmHg after oral antihypertensive therapy. 10. Active or clear history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea). 11. Severe infection occurring within 4 weeks prior to initial medication, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; Active infections that have received systemic anti-infective therapy within 10 days prior to initial dosing (exclud
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;progression free survival ; | — |
Countries
China
Contacts
Public ContactHongyan Guo
Peking University Third Hospital
Outcome results
None listed