| Eligibility |
Inclusion Criteria:
1. Age =18 years old
2. Understand the research procedures and content, and voluntarily sign informed consent
3. Histologically or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or
stage III-IVA cervical carcinoma with adenocarcinoma;
4. According to RECIST 1.1 criteria, subjects must have at least one of the following
risk factors demonstrated by CT or MRI or PET-CT:1) Pelvic lymph nodes with short
diameter =20mm and para-arterial lymph nodes with short diameter =10mm;2)The number of
lymph nodes > 2 (single lymph node with short diameter =10mm);
5. CT, MRI, or PET-CT showed no distant metastasis;
6. Expected survival period = 3 months
7. ECOG score: 0-1
8. Subject will provide sufficient formalin fixed paraffin embedded (FFPE) specimens or
sections of tumor archived tissue or fresh tissue that meet the test criteria and will
be willing to undergo tumor biopsy for PD-L1 if required. The archived tissue must be
a representative tumor specimen from less than 3 years old, or a series of unstained
sections (not less than 4) of FFPE tumor tissue from less than 6 months old, and the
relevant pathological report of the above specimens must be provided. Fresh tissue
samples can be obtained by surgical resection or biopsy. The methods of biopsy include
but are not limited to core needle biopsy, endoscopic resection or clamp biopsy
(ensure sufficient tumor cells > 100); Fine needle aspiration and liquid based
cytology (TCT) samples are not accepted (i.e. samples that lack complete tissue
structure and provide only cell suspension and/or cell smear); Demineralized specimens
of bone metastases were not accepted. For patients with pD-L1 negative initial
archived tumor tissue samples, biopsies may be performed at screening, subject to
patient consent, to provide fresh tissue prepared wax blocks or slices for retesting
for PD-L1 status.
9. Investigator-assessed suitability for concurrent chemoradiotherapy;
10. The values of laboratory tests performed for screening must meet the following
criteria:
Blood test 1) Hemoglobin (HGB) =90 g/L; 2) Absolute count of neutrophils (ANC)
=1.5×109 /L; 3) Platelet (PLT) =100×109 /L; Biochemical examination 1) Total bilirubin
(TBIL) =1.5×ULN (Gilbert syndrome allowed =5×ULN); 2) Alanine aminotransferase (ALT)
and aspartate aminotransferase (AST) =2.5×ULN (if liver metastasis exists, ALT and
AST=5×ULN); 3) Serum creatinine (Cr) =1.5×ULN or endogenous creatinine clearance
=50mL/min (Cockcroft Gault formula);
11. Thyroid function indicators: thyroid stimulating hormone (TSH) and free thyroid
hormone (FT3/FT4) were in the normal range; If TSH is not in the normal range, FT3 and
FT4 can be grouped if they are in the normal range.
12. The subjects can be followed up regularly, have good communication with the
researchers, and complete the study in accordance with the provisions of the study.
Exclusion Criteria:
1. Histological examination results are small cell (neuroendocrine) cervical cancer and
mucinous adenocarcinoma
2. CT, MRI or PET-CT examination shows diffuse pelvic metastasis
3. CT, MRI or PET-CT examination shows distant metastasis (excluding retroperitoneal
lymph node metastasis)
4. A patient with a previous malignancy (other than cured basal cell carcinoma of the
skin or squamous cell carcinoma) should not participate in the study unless she had a
complete response for at least 5 years prior to enrollment and was not expected to
require additional antitumor therapy during the study period;
5. Active central nervous system (CNS) metastases, including symptomatic brain
metastases,meningeal metastases or spinal cord compression, etc.Asymptomatic brain
metastases can be included in the group (no progression for at least 4 weeks after
radiotherapy and/or no neurological symptoms or signs after surgical resection, no
need for treatment with glucocorticoids, anticonvulsants or mannitol)
6. Systemic chemotherapy, targeted therapy, anti-tumor biological therapy (such as tumor
vaccine, cytokine or growth factor, etc.) have been performed before the study drug
7. The effect of major surgery or severe trauma before study medication has been
eliminated within 14 days(Those who have undergone local anesthesia or percutaneous
needle biopsy within 7 days and have recovered can be included in the group)
8. Participants received systemic corticosteroids (prednisone>10mg/day or equivalent
dose) or other immunosuppressive drugs within 14 days before the study medication
9. Have active, known history of autoimmune diseases, including but not limited to
systemic lupus erythematosus (sle), psoriasis, rheumatoid arthritis, inflammatory
bowel disease, hashimoto's thyroiditis, except: type I diabetes, only by hormone
replacement therapy can control the hypothyroidism, no systemic treatment of skin
diseases, such as vitiligo, and has celiac disease control;
10. Complications that require immunosuppressive drug therapy or systemic treatment at
immunosuppressive doses (prednisone > 10mg/ day or equivalent dose of the same drug);
In the absence of active autoimmune disease, inhaled or topical steroids and doses >
10mg/ day of prednisone or equivalent doses of similar drugs are permitted;
11. Uncontrolled hypertension (systolic blood pressure > 140 mmHg and/or diastolic blood
pressure > 90 mmHg) or pulmonary hypertension or unstable angina; Myocardial
infarction or bypass or stent surgery within 6 months before administration; A history
of chronic heart failure that meets New York Heart Association (NYHA) criteria of
grade 3-4; Valvular disease of clinical significance; Severe arrhythmias requiring
treatment, including QTc interval =470 ms (as calculated by Fridericia formula); Left
ventricular ejection fraction (LVEF) < 50%; Cerebrovascular accident (CVA) or
transient ischemic attack (TIA) within 6 months before administration;
12. Other serious medical diseases, including but not limited to: uncontrolled diabetes,
active digestive ulcer, active bleeding, etc.;
13. Actively infected persons requiring systemic treatment;
14. Previously or currently infected with active TUBERCULOSIS;
15. Previous history of interstitial lung disease;
16. Symptomatic and uncontrollable serous effusion such as peritoneal, pleural, or
pericardial effusion;
17. Human immunodeficiency virus antibody (HIV-AB) positive; Active syphilis infection;
Hepatitis C antibody (HCV-AB) positive, and HEPATITIS C virus RNA quantitative > the
upper limit of detection unit normal value; Hepatitis B virus surface antigen (HBsAg)
positive, and hepatitis B virus detection value > the upper limit of normal value of
the detection unit;
18. The adverse reactions caused by previous treatment have not recovered to level 1 or
below (CTCAE5.0) (except for alopecia and level 2 neurotoxicity caused by chemotherapy
drugs);
19. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or
any other antibody acting on the T cell costimulation or checkpoint pathway);
20. Previous radiation therapy has been performed for the area to be irradiated;
21. Use of live or attenuated vaccine within 28 days prior to the study administration;
22. Use of any other study drug or research device within 30 days prior to the study
medication;
23. Those with a history of drug abuse or drug abuse upon inquiry;
24. Previous clear history of neurological or mental disorders, such as epilepsy,
dementia, poor compliance;
25. Breastfeeding women who do not agree to stop breastfeeding;
26. Known allergy to recombinant humanized PD-1 monoclonal antibody or any of its
excipients; Known history of allergic disease or severe allergic constitution;
27. The investigator considers that it is not suitable to participate in this clinical
investigator due to various other reasons.
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