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This is a Phase II study of neoadjuvant therapy of AK104 combined with nab-paclitaxel/carboplatin in fertility saving surgery for stage IB2-IB3 cervical cancer (FIGO 2018). The main questions it aims to answer are:
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Inclusion criteria
Voluntarily sign a written ICF.
Age ≥ 18 years old and ≤ 45 years old at the time of enrollment.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Patients with histologically confirmed (2018 FIGO) stage IB2-IB3 cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma.
Imaging evaluation showed no distant metastasis or regional lymph node metastasis, and the tumor was limited to the cervix.
Have not received any systemic or local anti-tumor treatment for cervical cancer before the first medication, including radiotherapy, chemotherapy, immunotherapy, biological agents, small molecule targeted therapy, etc.
Patients who require preservation of reproductive function and who are judged by the researcher to have no contraindications to childbirth surgery.
At least 1 untreated measurable lesion according to RECIST v1.1.
Subjects agree to collect tumor tissue and peripheral blood samples required during the screening period and research process and use them in related research.
With good organ function:
a) Hematology (no blood components and cell growth factor support therapy were used within 7 days before starting study treatment): i. Absolute neutrophil count ANC ≥ 1.5 × 109/L (1,500/mm3); ii. Platelet count ≥ 100 × 109/L (100,000/mm3); iii. Hemoglobin ≥ 90 g/L. b) Kidney: i. Calculated creatinine clearance* (CrCl) ≥ 50 mL/min
* CrCl will be calculated using the Cockcroft-Gault formula (Cockcroft-Gault formula) CrCl (mL/min) = {(140 - age) × weight (kg) × 0.85}/ (serum creatinine. (mg/dL) × 72) ii .Urine protein < 2+ or 24-hour (h) urine protein quantification < 1.0 g.
c) Liver: i. Serum total bilirubin (TBil) ≤ 1.5 × ULN ii. AST and ALT ≤ 2.5× ULN iii. Serum albumin (ALB) ≥ 28 g/L d) Coagulation function: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (e.g.
If the subject is receiving anticoagulant therapy, the subject must receive a stable dose of anticoagulant and have coagulation during screening.
Parameters (PT/INR and APTT) were within the expected range for anticoagulant therapy).
e) Heart function: i. Left ventricular ejection fraction (LVEF) ≥ 50%.
Female subjects with childbearing potential must undergo a urine or serum pregnancy test within 3 days before taking the drug for the first time (if the urine pregnancy test result cannot be confirmed to be negative, a serum pregnancy test must be performed, and the serum pregnancy result shall prevail). and the result was negative. If a female subject of childbearing potential has sexual intercourse with a non-sterilized male partner, the subject must use an acceptable method of contraception since screening and must agree to continue using contraception methods for 120 days after the last dose of the study drug. Whether to discontinue contraception after this time point should be discussed with the investigator. Cyclic abstinence and safe period contraception are unacceptable methods of contraception.
Subjects are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other requirements of the study.
Exclusion criteria
Patients with a 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 the first administration; Patients suffered any arterial thromboembolic event, NCI CTCAE version 5.0 grade 3 or above, venous thromboembolism, transient ischemic attack, cerebrovascular accident, hypertensive crisis or hypertensive encephalopathy within 6 months before the first dose; Patients with acute exacerbation of COPD within 1 month before first dose; Current hypertension with systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg after treatment with oral antihypertensive drugs.
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
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Central trial contact
Jin Li
Data sourced from clinicaltrials.gov
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