cervical cancer
Conditions
Interventions
experimental group:Cardunizumab 6mg/kg+Albumin bound paclitaxel 200mg/m2+cisplatin 75mg/m2 q3w * 2 courses
Three weeks after the completion of induction chemotherapy, concurrent radiotherapy and chemotherapy (cisplatin 40mg/m2, d1 qw * 4-6 courses) were performed
The external irradiation adopts three-dimensional conformal intensity modulation technology, with a radiation type of 6MV X-ray. The prescription dose is PCTV with a dose of 45Gy/25f or 50.4Gy/28f, PG
Sponsors
Cancer Hospital Affiliated to Guangzhou Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Pathological or cytological diagnosis of cervical cancer, including squamous cell carcinoma, adenosquamous cell carcinoma, and adenocarcinoma. 2. Without any anti-tumor treatment (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy, and immunotherapy). 3. FIGO 2018 is divided into IB3, IIA2-IVA stages, with an expected survival period of = 3 months; Confirmed no distant metastasis. 4. At least one measurable lesion (RECIST 1.1 standard) with a tumor short diameter of = 5cm, or a fused lymph node with a lymph node short diameter of = 1.5cm. 5. Age 18-70 years old and KPS score = 70. 6. Important organs function well before radiotherapy: bone marrow, heart, liver, kidneys, and nervous system function are basically normal: meet the following laboratory examination parameters a. Peripheral blood count: Neutrophils (ANC) = 1.5 × 10 ^ 9/L, platelet count (PLT) = 100 × 10 ^ 9/L, hemoglobin (Hgb) = 9.0 g/dL; b. Renal function: serum creatinine = 1.5 * ULN or calculated creatinine clearance rate (CrCl) = 50 mL/min (attached Cockcroft Gault formula); c. Liver: serum total bilirubin (TBil) = 1.5 * ULN; Subjects with evidence confirming/suspecting Gilbert disease, TBil = 3 * ULN; AST and ALT = 2.5 * ULN; d. Coagulation function: International standardized ratio (INR) = 1.5 × ULN and activated partial thromboplastin time (APTT) = 1.5 × ULN (If the subject is receiving anticoagulant treatment, the subject must receive a stable dosage of anticoagulant and the coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant treatment at the screening). 7. Pregnancy test negative within 24 hours before the first medication use (only for women of childbearing age) 8. Follow up regularly; Able to comply with experimental requirements; 9. Sign an informed consent form for treatment.
Exclusion criteria
Exclusion criteria: 1. Subjects with cervical cancer of other histopathological types; I have undergone a total hysterectomy (removal of the uterine body and cervix). 2. There is evidence of distant metastasis, including inguinal lymph node metastasis and lymph node metastasis above the level of the proximal L1 vertebral body. 3. Patients with other active malignant tumors within the first 2 years of randomization, except for those with locally curable tumors that appear to have been cured. 4. Refuse to receive close range radiotherapy due to anatomical abnormalities or other reasons. 5. Receiving other anti-tumor treatments before treatment, including radical surgery, palliative surgery, and receiving radiotherapy or intravenous chemotherapy before radiotherapy and chemotherapy; Previously received any treatment targeting tumor immune mechanisms such as immune checkpoint inhibitors or immune co stimulators; Received medication with immunomodulatory effects within the first 2 weeks of randomization. 6. There is clinically significant bilateral hydronephrosis that cannot be relieved through nephrostomy or ureteral stent placement, as determined by the researchers. 7. Subjects who require systemic treatment with corticosteroids (>10 mg/day prednisone or equivalent doses of corticosteroids) or other immunosuppressive drugs within the first 2 weeks of randomization; Except for the following: a) Allowing inhalation, ophthalmic, or local use of prednisone at a dose of = 10 mg/day or equivalent doses of glucocorticoids for treatment. b) Physiological glucocorticoid replacement therapy, with a dosage of = 10 mg/day of prednisone or equivalent doses of glucocorticoids. c) Glucocorticoids are used as a preventive medication for hypersensitivity reactions (such as medication before CT examination). 8. Any of the following cardiovascular and cerebrovascular diseases: a) Hypertension (defined as systolic blood pressure>150 mmHg and diastolic blood pressure>100 mmHg) that cannot be controlled after sufficient treatment with antihypertensive drugs, or a history of hypertension crisis or hypertensive encephalopathy; b) Myocardial infarction, unstable angina, pulmonary embolism, aortic dissection, deep vein thrombosis, and any arterial thromboembolism events occurred within the first 6 months of randomization; c) Heart failure with a New York Heart Association (NYHA) heart function rating of = II; d) There are severe arrhythmias that require long-term drug intervention; Allowing admission to asymptomatic and stable ventricular rate patients with atrial fibrillation; e) Cerebrovascular events (CVA) occurred within the first 6 months of randomization; f) Left ventricular ejection fraction (LVEF)<50%; g) Previous history of myocarditis or cardiomyopathy. 9. Serious infection or major surgical treatment or use of live vaccines within the first 4 weeks of randomization; Selective major surgical treatment is required during the study period. 10. Suffering from active or potentially recurrent autoimmune diseases; There are active infections that require systemic treatment. 11. Have other serious medical history, such as active or documented inflammatory bowel disease or active diverticulitis; History of allogeneic organ transplantation and hematopoietic stem cell transplantation, history of interstitial lung disease or non infectious pneumonia, and history of severe hypersensitivity to other monoclonal antibodies. 12. Those who have any contraindications or develop severe allergi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor shrinkage rate after CCRT; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year progression free survival rate;Objective response rate after induction chemotherapy and CCRT;Overall Survival;Adverse event occurrence rate; | — |
Countries
CHINA
Contacts
Public ContactLi Mingyi
Cancer Hospital Affiliated to Guangzhou Medical University
Outcome results
None listed