Cervical cancer
Conditions
Interventions
Neoadjuvant therapy group:Adebrelimab + paclitaxel + cisplatin/carboplatin
Sponsors
The Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: subjects must meet all of the following criteria to be enrolled. 1. Age 18 ~ 70 years old; 2. The subject must have a histopathological diagnosis of cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adeno-squamous cell carcinoma; 3. Locally advanced cervical cancer with clinical stage IB3, IIA2 or IIB/IIIC1r with local tumor diameter =4cm determined by gynecological examination (FIGO, 2018 standard); 4.ECOG score 0-1. 5. Adequate organ and bone marrow function (no blood transfusion within 14 days, no hematopoietic stimulating drugs) : blood routine: neutrophil =1.5×109/L, platelets =100×109/L, hemoglobin =9.0 g/dL; Liver function: total bilirubin =1.5×ULN (Gilbert syndrome subjects =3×ULN); ALT/AST=2.5 x ULN; Renal function: serum creatinine =1.5×ULN, or creatinine clearance =40 mL/min (Cockcroft-Gault formula); The left ventricular ejection fraction (LVEF) measured by echocardiography was > 50%. 6. Preoperative pathological examination showed positive expression of PD-L1, that is, Combined Positive Score (CPS) =1; 7. Ability to sign informed consent, including compliance with the ICF and the requirements and restrictions outlined in this protocol; 8. Can follow up, good compliance.
Exclusion criteria
Exclusion criteria: Exclusion criteria: subjects with one of the following conditions were excluded. 1. 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 a past hypertensive crisis or hypertensive encephalopathy; 2. Major surgical procedures (craniotomy, thoracotomy, or laparotomy) within 28 days or unhealed wounds, ulcers, or fractures at the time of screening; 3. Previous treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; A known allergy to any ingredient of drugs in this trial or to other monoclonal antibodies. 4. Active, known, or suspected autoimmune disease; 5. Any serious active infection, including active tuberculosis, that requires systemic antimicrobial, antifungal or antiviral treatment at the time of screening; 6. Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS); 7. Immunosuppressive drugs or systemic corticosteroids (> 10mg/day of prednisone or other equivalent drugs) were administered within 2 weeks; 8.Active malignancy other than cervical cancer within 5 years. Cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, breast carcinoma in situ, etc., could be included. 9. Pregnant, lactating women, female subjects of childbearing age or her partners do not agree; 10. Participate in other clinical trials; 11. Interference factors with the process of participants' participation, the subjects' maximum benefit from the study or final research results are evaluated by investigator, such as a history of mental illness, drug abuse, substance abuse, any other disease or condition of clinical significance, and a history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;MPR;cCR;OS;EFS; | — |
Countries
China
Contacts
Public ContactQinglian Wen
The Affiliated Hospital of Southwest Medical University
Outcome results
None listed