Neoadjuvant Immunochemotherapy in PD-L1-negative LACC

Inclusion Criteria:

1. FIGO 2018 stage IB3, IIA2, or IIB/IIIC1r (tumor size>4cm) cervical cancer andwithout any treatment (After undergoing gynecological examinations by two associatechief physicians or above, the staging of the patients was determined);

2. Has at least one measurable lesion based on Response Evaluation Criteria in SolidTumours (RECIST) version 1.1. In principle, the size of the lesion as shown by themagnetic resonance imaging examination is used as the criterion.

3. Histologically confirmed squamous carcinoma, adenocarcinoma (common type) oradenosquamous carcinoma of the cervix;

4. Negative PD-L1 expression on preoperative pathological examination (Combinedpositive score < 1);

5. 18-70 years of age;

6. Eastern Cooperative Oncology Group score ≤ 1;

7. WBC≥3.510^9/L, NEU≥1.510^9/L, Platelet≥100×10^9 /L; AST and ALT ≤1.5 times normalupper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serumcreatinine 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 therequirements and limitations outlined in the Informed Consent Form (ICF) and thisform.

Exclusion Criteria:

1. Active, known, or suspected autoimmune disease, or a history of an autoimmunedisease, 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 hormonereplacement therapy (due to autoimmune thyroiditis), type 1 diabetes that requiresonly stable doses of insulin replacement therapy, asthma that subsides completely inchildhood and does not require intervention in adulthood, or diseases that do notrecur 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 againstimmune co-stimulators (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40targets, 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 prescribedmedication;

4. Immunosuppressive drugs or systemic corticosteroids for immunosuppression (> mg/dayof 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 limitedto complications requiring hospitalization, sepsis, or severe pneumonia;

8. Patients with untreated chronic hepatitis B, or HBV carriers with chronic hepatitisB 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 andare in stable condition (HBV < 1000 IU/mL), and patients with cured hepatitis C areeligible for enrollment. HCV antibody-positive subjects will be eligible for thestudy only if they have a negative HCV RNA test;

9. Known active tuberculosis (TB), patients with suspected active TB should undergochest X-ray and sputum examination in conjunction with clinical signs and symptomsfor 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 unableto swallow or who have malabsorption syndrome, uncontrolled nausea, vomiting,diarrhea, or other gastrointestinal disorders that severely interfere with drugintake and absorption;

12. Known interstitial lung disease that is symptomatic or may interfere with detectionor treatment of immune-associated pneumonia;

13. Treatment with a live or attenuated vaccine administered within 4 weeks prior to thefirst 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 infusiondevice is permitted;

17. With a history of gastrointestinal perforation, gastrointestinal fistula, or femalegenital fistula;

18. Uncontrolled other co-morbidities, symptoms, or medical history, including (i)persons with one of the following cardiovascular diseases or cardiovascular riskfactors: myocardial infarction, unstable angina, pulmonary embolism,acute/continuous myocardial ischemia, cerebral vascular accident, transient ischemicattack, or other arterial or venous thrombosis, embolism, or cerebral ischemic eventof clinical significance/requiring pharmacologic intervention; and persons who havehad, within 6 months, a symptoms of congestive heart failure (New York HeartAssociation (NYHA) class III and above); (ii) clinically significant bleedingsymptoms or a history of significant bleeding characteristics such asgastrointestinal bleeding, gastric ulcer bleeding, or vasculitis within 1 monthprior to the first dose; (iii) clinically active hemoptysis, active diverticulitis,abdominal abscesses, and gastrointestinal obstruction; and (iv) uncontrolled pleuraleffusion, pericardial effusion, or ascites requiring Repeated drainage of ascites; ⑤Abnormal liver or kidney development or history of surgery;

19. Pregnant or breastfeeding female patients; women of childbearing age who refuse toaccept contraceptive measures during neoadjuvant immunotherapy;

20. Concurrent participation in other interventional clinical trials; participation inobservational and non-interventional clinical trials is permitted;

21. Any condition that, in the judgment of the investigator, may result in risk in thereceipt of the study drug or that would interfere with the evaluation of the safetyof the study drug or the interpretation of the study results. Patients who, in thejudgment of the Investigator, are unlikely to comply with the study steps,restrictions, and requirements are not permitted to participate in this study.