| Eligibility |
Inclusion Criteria:
1. FIGO 2018 stage IB3, IIA2, or IIB (tumor size=4cm) cervical cancer and without any
treatment (After undergoing gynecological examinations by two associate chief
physicians or above, the staging of the patients was determined);
2. Has at least one measurable lesion based on Response Evaluation Criteria in Solid
Tumours (RECIST) version 1.1. In principle, the size of the lesion as shown by the
magnetic resonance imaging examination is used as the criterion.
3. Histologically confirmed squamous carcinoma, adenocarcinoma (common type) or
adenosquamous carcinoma of the cervix;
4. Negative PD-L1 expression on preoperative pathological examination (Combined positive
score < 1);
5. 18-70 years of age;
6. Eastern Cooperative Oncology Group score = 1;
7. WBC=3.5*10^9/L, NEU=1.5*10^9/L, Platelet=100×10^9 /L; AST and ALT =1.5 times normal
upper limit; Total bilirubin =1.5 times the upper limit of normal value; serum
creatinine and blood urea nitrogen =the upper limit of normal value;
8. Well-compliance and willing to keep in touch;
9. Willing to participate in this study, sign the informed consent, and comply with the
requirements and limitations outlined in the Informed Consent Form (ICF) and this
form.
Exclusion Criteria:
1. Active, known, or suspected autoimmune disease, or a history of an autoimmune disease,
except for the following: vitiligo, alopecia areata, Graves's disease, psoriasis, or
eczema that has not required systemic therapy within the last 2 years, hypothyroidism
that is asymptomatic or requires only stable doses of hormone replacement therapy (due
to autoimmune thyroiditis), type 1 diabetes that requires only stable doses of insulin
replacement therapy, asthma that subsides completely in childhood and does not require
intervention in adulthood, or diseases that do not recur in the absence of external
triggers;
2. Prior treatment with immune checkpoint inhibitors, including, but not limited to,
other anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or antibodies against
immune co-stimulators (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40 targets,
etc.), or any other therapy targeting a tumor's immune mechanism of action;
3. Known hypersensitivity to any component and/or any excipient of the trial prescribed
medication;
4. Immunosuppressive drugs or systemic corticosteroids for immunosuppression (> mg/day of
prednisone or other equivalent) within 2 weeks prior to trial dosing; topical,
ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are permitted;
5. Received herbs with antitumor effects or drugs with immunomodulatory effects (e.g.,
thymidine, interferon, interleukin-2) within 2 weeks prior to the trial;
6. Active systemic infection requiring systemic treatment;
7. Serious infection within 4 weeks prior to the first dose, including but not limited to
complications requiring hospitalization, sepsis, or severe pneumonia;
8. Patients with untreated chronic hepatitis B, or HBV carriers with chronic hepatitis B
virus (HBV) DNA greater than 1,000 IU/mL, or patients with active hepatitis C.
Inactive HBsAg carriers, patients with hepatitis B who have received treatment and are
in stable condition (HBV < 1000 IU/mL), and patients with cured hepatitis C are
eligible for enrollment. HCV antibody-positive subjects will be eligible for the study
only if they have a negative HCV RNA test;
9. Known active tuberculosis (TB), patients with suspected active TB should undergo chest
X-ray and sputum examination in conjunction with clinical signs and symptoms for
exclusion;
10. Immunodeficiency or human immunodeficiency virus (HIV antibody positive);
11. Subjects with active inflammatory bowel disease or a history of such disease (e.g.,
Crohn's disease, ulcerative colitis, or chronic diarrhea). Subjects who are unable to
swallow or who have malabsorption syndrome, uncontrolled nausea, vomiting, diarrhea,
or other gastrointestinal disorders that severely interfere with drug intake and
absorption;
12. Known interstitial lung disease that is symptomatic or may interfere with detection or
treatment of immune-associated pneumonia;
13. Treatment with a live or attenuated vaccine administered within 4 weeks prior to the
first trial dose, inactivated seasonal influenza virus vaccine is permitted;
14. Have received a prior allogeneic bone marrow transplant or solid organ transplant;
15. History of primary malignant tumor within the last 5 years;
16. Have undergone major surgery (e.g., open abdomen, open chest, organ resection, etc.)
and severe trauma within 28 days prior to the first dose of the implantable infusion
device is permitted;
17. With a history of gastrointestinal perforation, gastrointestinal fistula, or female
genital fistula;
18. Uncontrolled other co-morbidities, symptoms, or medical history, including (i) persons
with one of the following cardiovascular diseases or cardiovascular risk factors:
myocardial infarction, unstable angina, pulmonary embolism, acute/continuous
myocardial ischemia, cerebral vascular accident, transient ischemic attack, or other
arterial or venous thrombosis, embolism, or cerebral ischemic event of clinical
significance/requiring pharmacologic intervention; and persons who have had, within 6
months, a symptoms of congestive heart failure (New York Heart Association (NYHA)
class III and above); (ii) clinically significant bleeding symptoms or a history of
significant bleeding characteristics such as gastrointestinal bleeding, gastric ulcer
bleeding, or vasculitis within 1 month prior to the first dose; (iii) clinically
active hemoptysis, active diverticulitis, abdominal abscesses, and gastrointestinal
obstruction; and (iv) uncontrolled pleural effusion, pericardial effusion, or ascites
requiring Repeated drainage of ascites; ? Abnormal liver or kidney development or
history of surgery;
19. Pregnant or breastfeeding female patients; women of childbearing age who refuse to
accept contraceptive measures during neoadjuvant immunotherapy;
20. Concurrent participation in other interventional clinical trials; participation in
observational and non-interventional clinical trials is permitted;
21. Any condition that, in the judgment of the investigator, may result in risk in the
receipt of the study drug or that would interfere with the evaluation of the safety of
the study drug or the interpretation of the study results. Patients who, in the
judgment of the Investigator, are unlikely to comply with the study steps,
restrictions, and requirements are not permitted to participate in this study.
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