| Eligibility |
Inclusion Criteria:
1. The subjects understand and voluntarily participate in the study, sign the informed
consent form (ICF), have good compliance, and cooperate with follow-up;
2. Female, 18 years of age =75 years of age on the date of signing the informed consent;
3. Cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma confirmed
by histopathology or cytology;
4. FIGO 2018 consists of patients with stage IIB - IVA. Note: Lymph nodes with confirmed
metastasis are required for diagnosis of stage ?C1. Lymph node metastasis diagnosis
can be confirmed by biopsy or imaging diagnosis, and the following criteria must be
met for imaging diagnosis of lymph node metastasis: MRI or CT showing positive lymph
nodes (minimum transverse diameter =15 mm)
5. Have not previously received any radical surgery, radiotherapy or systemic treatment
(including investigational drugs) for cervical cancer, and have not received
immunotherapy;
6. An American Eastern Oncology Collaboration (ECOG) score of 0 or 1 within 7 days prior
to the first study intervention;
7. There is at least one measurable lesion that meets the requirements of RECIST v1.1
standard (tumor lesion with CT scan diameter =10mm, lymph node lesion with CT scan
diameter =15mm, and scan layer thickness 5mm);
8. Expected survival =6 months;
9. The major organs function normally and meet the following criteria:
(1) Blood routine examination must meet:
1. Hemoglobin (Hb)=90g/L
2. White blood cell count (WBC)=3×109/L
3. Neutrophil count absolute value (ANC)=1.5×109/L
4. Platelet count (PLT)=100×109/L; (2) Biochemical examination shall meet the following
standards:
a. Serum total bilirubin (TBIL) =1.5 × ULN (total bilirubin (BIL)=3.0 mg/dL in patients
diagnosed with Gilbert syndrome) b. Alanine aminotransferase (ALT) and aspartate
aminotransferase (AST)=3ULN c. Albumin (ALB) =3 g/dL d. Serum Cr=1.5ULN, endogenous
creatinine clearance =60ml/min (Cockcroft-Gault formula); (3) The coagulation function test
shall meet the following criteria:
1. International Standardized Ratio (INR) =1.5
2. Activated partial thromboplastin time (APTT) =1.5 ×ULN; 10. In potentially fertile
women, serum or urine HCG negative for 72 hours prior to enlistment (postmenopausal
women must be considered infertile for at least 12 months and a pregnancy test is not
required for women who have been confirmed to have undergone tubal ligation), Female
subjects of reproductive age and male subjects with a partner of a woman of
reproductive age must consent to contraception for 24 weeks from the date of signing
the informed consent to the last administration of the study drug.
Exclusion Criteria:
1. Subjects have histological subtypes other than those permitted by inclusion criteria
3;
2. Evidence of metastatic lesions according to RECIST 1.1 (including proximal L1 level or
above or inguinal regional lymph nodes);
3. Have had a hysterectomy (defined as removal of the entire uterus) or had a
hysterectomy as part of their initial treatment for cervical cancer;
4. Bilateral hydronephrosis, which the investigators judged could not be relieved by
nephrostomy or ureteral stenting;
5. Patients with uncontrolled vaginal bleeding;
6. Previous allergy to any investigational drug ingredient;
7. Participate in clinical studies of other investigational drugs within 3 months prior
to screening;
8. Other malignancies developed within 5 years prior to admission, excluding adequately
treatable basal cell or squamous cell skin cancer, local prostate cancer after radical
surgery, and ductal carcinoma in situ after radical surgery;
9. Have any active autoimmune disease or history of autoimmune disease (such as
interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis,
myocarditis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to
these diseases or syndromes); Except for patients with vitiligo or childhood
asthma/allergies that have healed and do not require any intervention as adults;
Autoimmune mediated hypothyroidism treated with a steady dose of thyroid replacement
hormone; Type 1 diabetes using steady doses of insulin;
10. A history of immunodeficiency, including HIV testing positive, or other acquired or
congenital immunodeficiency diseases, or a history of organ transplantation and
allogeneic bone marrow transplantation;
11. Accompanied by serious heart, lung, liver, kidney disease; Having neurological or
mental illness; Jaundice or digestive tract obstruction with severe infection;
12. Patients with hypertension who are not well controlled by antihypertensive drugs
(systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg); Or grade II
or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias
(including QTc interval =450ms for men and =470ms for women); According to NYHA
criteria, patients with grade ? to ? cardiac insufficiency or left ventricular
ejection fraction (LVEF) < 50% indicated by cardiac color ultrasound;
13. Urine routine suggests urinary protein =(++), or 24h urinary protein =1g or severe
hepatic and renal insufficiency;
14. Patients with Crohn's disease and ulcerative colitis;
15. Subjects who have received systemic treatment with corticosteroids (>10 mg/ day of
prednisone or other equivalent hormones) or other immunosuppressants within 2 weeks
prior to initial dosing. In the absence of active autoimmune disease, inhaled or
topical corticosteroids are permitted, as well as adrenal hormone replacement therapy
at doses =10 mg/ day of prednisone efficacy;
16. Pregnant or lactating women, fertile subjects unwilling or unable to take effective
contraceptive measures;
17. Those deemed unsuitable for inclusion by the researchers.
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