Cervical Cancer
Conditions
Interventions
Experimental group:Enlonstobart Injection + Paclitaxel for Injection ( Albumin Bound) + Carboplatin
Sponsors
Jilin Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old; 2. Cervical squamous cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma confirmed by histology or cytopathology; 3. Cervical cancer patients with locally advanced tumors who have not received any treatment and have FIGO stages of IB3, IIA2 in 2018; 4. ECOG score 0-1; 5. Left ventricular ejection fraction (LVEF)>=50%; 6. Bone marrow function: absolute neutrophil count (ANC) >=1.5×109/L, hemoglobin >=90g/dL, platelets (PLT) >= 100×109/L; 7. Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) 1.5×ULN, creatinine clearance >=60 mL/min (calculated according to Cockcroft-Gault formula); 9. Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international standardized ratio (INR) <=1.5×ULN; 10. The patient had at least one evaluable lesion according to RECIST1.1 criteria; 11. The patient of childbearing age has a negative pregnancy test and voluntarily takes effective and reliable contraceptive measures during the test; 12. Volunteer to participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Active malignancies within 3 years prior to first dosing, other than cervical cancer studied in this trial and any locally curable tumors that have undergone radical treatment (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, or cured carcinoma in situ, such as breast carcinoma in situ); 2. Have active tuberculosis or have a history of it; 3. Have had interstitial lung disease, or need glucocorticoid treatment of non-infectious pneumonia; 4. Patients with hypertension and whose blood pressure has not been satisfactorily controlled by antihypertensive drugs (defined as systolic blood pressure > 150 mmHg, or diastolic blood pressure > 90 mmHg), who have had hypertensive crises or hypertensive encephalopathy in the past; 5. Severe cardiovascular disease in the 6 months prior to randomization, including but not limited to: stable angina pectoris with functional classification III-IV; Unstable angina pectoris or myocardial infarction; NYHA Class III-IV congestive heart failure; Severe arrhythmias requiring medical treatment (if ventricular rate can be controlled, subjects with asymptomatic atrial fibrillation are allowed to be included); Severe arterial/venous thrombosis events (such as cerebral hemorrhage, cerebral infarction, deep vein thrombosis and pulmonary embolism); 6. Have an active autoimmune disease, or have a history of autoimmune disease within 2 years prior to randomization, and still require systemic treatment. However, subjects with well-controlled type 1 diabetes, well-controlled hypothyroidism requiring only hormone replacement therapy, skin conditions that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss), or whose condition is not expected to recur in the absence of external triggers, are allowed to be further screened. 7. Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS); 8. Subjects with uncontrolled pleural effusion, pericardial effusion, or abdominal and pelvic effusion requiring repeated drainage; 9. Immunosuppressive drug or systemic corticosteroid treatment within 2 weeks prior to trial administration for immunosuppressive purposes (> 10mg/day of prednisone or other equivalent drugs); 10. Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures at the time of screening within 28 days prior to the initial study drug treatment; 11. Previous allogeneic stem cell transplantation or organ transplantation; 12. There are circumstances in which other investigators deem it unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR);Progression-free survival(PFS);Overall survival(OS);2-year PFS rate;2-year overall survival (OS) rate; | — |
Countries
China
Contacts
Public ContactZhou Li
Jilin Cancer Hospital
Outcome results
None listed