Phase II Study on Neoadjuvant Therapy of AK104 Combined With Nab-paclitaxel/Carboplatin in Fertility Preserving Surgery

Exclusion Criteria

• •The histopathological types are small cell carcinoma, gastric adenocarcinoma, etc.
• •In addition to cervical cancer, subjects suffered from other malignant tumors within 3 years before enrollment. Subjects with other malignant tumors that have been cured by local treatment, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, breast cancer, etc., are not excluded.
• •Enroll in another clinical study at the same time, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study.
• •Patients with distant tumor metastasis or local and regional lymph node metastasis.
• •Patients who received non-specific immunomodulatory therapy (such as interleukins, interferons, thymosin, tumor necrosis factor, etc., excluding IL-11 used to treat thrombocytopenia) within 2 weeks before the first medication; Received non-specific immunomodulatory therapy within 1 week before the first medication Chinese herbal medicine or Chinese patent medicine with anti-tumor indications.
• •Suffering from active autoimmune diseases that require systemic treatment (such as disease-modifying drugs, corticosteroids, immunosuppressive treatment), Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a systemic therapy.
• •Patients have a history of non-infectious pneumonia or pneumonia requiring systemic glucocorticoid treatment or a current history of interstitial lung disease.
• •With a history of severe bleeding tendency or coagulation disorder.
• •Patients with currently uncontrolled comorbid diseases, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or a mental illness/social condition that would limit the subject's ability to comply with research requirements or affect the subject's ability to provide written informed consent.
• •Patients with history of myocarditis, cardiomyopathy, and malignant arrhythmia. Patients suffered unstable angina, congestive heart failure or vascular disease requiring hospitalization (such as aortic aneurysm or peripheral venous thrombosis requiring surgical repair) within 12 months before the first dose, or other heart damages (such as poorly controlled arrhythmia, myocardial infarction or ischemia) that may affect the safety evaluation of the study.
• •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.
• •Patients with active or clear history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis or chronic diarrhea).
• •Patients with serious infection occurring within 4 weeks before the first dose, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia; Patients with active infection (excluding antiviral therapy for hepatitis B or hepatitis C) that has been treated with systemic anti-infectious therapy within 10 days before the first dose.
• •Patients suffered major surgery or serious trauma within 30 days before the first medication; or minor local surgery within 3 days before the first medication (excluding central venous catheterization via peripheral venipuncture).
• •Patients with a history of immunodeficiency; those with positive HIV antibody test; Patients who are taking long-term systemic corticosteroids or other immunosuppressants.
• •Subjects who are known to have active pulmonary tuberculosis (TB) and are suspected of having active TB need to undergo clinical examination to exclude (such as sputum tuberculosis bacilli examination, chest X-ray, etc.); known active syphilis infection.
• •Patients with history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• •Subjects with untreated active hepatitis B (HBsAg positive and HBV-DNA exceeding 1000 copies/ml (200 IU/ml) or higher than the lower limit of detection).Subjects with hepatitis B are required to receive anti-hepatitis B virus treatment during the study treatment period; subjects with active hepatitis C (HCV antibody positive and HCV-RNA levels above the lower limit of detection).
• •Patients who have received a live vaccine within 30 days before the first dose, or plan to receive a live vaccine during the study.
• •Patients who are hypersensitive to any component of any study drug; with history of severe hypersensitivity reactions to other monoclonal antibodies.
• •Patients with history of mental illness, substance abuse, alcoholism, or drug abuse.
• •Pregnant or lactating women.
• •Patients with any past or current disease, treatment, or laboratory test abnormality may confuse the research results and affect the subject's full participation in the research, or participation in the research may not be in the best interests of the subject.