Efficacy and Safety of AK104 (PD-1/CTLA-4 Bispecial Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer

Inclusion Criteria:

1. Agree to sign the informed consent form.

2. 18 years ≤ age <75 years, female.

3. Patients with epithelial ovarian cancer (high-grade serous adenocarcinoma, ovarianendometrial carcinoid adenocarcinoma), peritoneal or fallopian tube carcinoma, orclear cell carcinoma confirmed by histopathology, FIGO 2018 stage III-IV.

4. Evidence of compliance with neoadjuvant chemotherapy for ovarian cancer: (a)Preoperative evaluation by gynecologic oncologists (multidisciplinary if necessary)indicates that R0 resection is less likely to be achieved after primary tumorreduction; (b) Patients whose physical state cannot tolerate PDS and are notsuitable for immediate surgery (such as perioperative high risk, old age, medicalcomplications, etc.); (c) Without any systematic anti-tumor therapy for ovariancancer (including but not limited to radiotherapy, chemotherapy, surgery, targetedtherapy and immunotherapy); Note: Histopathology is obtained by puncture biopsy,laparoscopic exploration, etc. Lymph node resection or biopsy for clinical stagingpurposes is permitted.

5. Those with at least one measurable lesion (RECIST version 1.1).

6. ECOG Physical status score 0-2.

7. Estimated survival time > 12 weeks.

8. Good organ function.

9. Participants of reproductive age must agree to use effective contraception duringthe trial; Serum or urine pregnancy tests for women of childbearing age must benegative.

10. Non-lactating patients.

Exclusion Criteria:

1. Ovarian cancer, fallopian tube cancer, primary peritoneal cancer (such as germ celltumor) of non-epithelial origin; Ovarian tumors with low malignant potential (e.g.,borderline tumors).

2. Patients with other malignant tumors in the past (within 5 years) or at the sametime, with the exception of cured local tumors (such as basal cell skin cancer,squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ,breast carcinoma in situ, etc.) and breast cancer with no recurrence >3 years afterradical surgery.

3. Subjects with active viral hepatitis B, inactive or asymptomatic hepatitis B virus (HBV) carriers (HBV surface antigen [HBsAg] positive) with HBV DNA > 1000 IU/mL, andsubjects with active viral hepatitis C. Note: Inactive or asymptomatic carriers,treated and stable hepatitis B subjects with HBV DNA ≤ 1000 IU/mL were admitted.Subjects with cured viral hepatitis C, HCVAb positive and HCV RNA negative wereadmitted.

4. A history of testing positive for known human immunodeficiency virus or knownacquired immunodeficiency syndrome.

5. Have an active or possibly recurring autoimmune disease; The following are excluded:vitiligo, alopecia, psoriasis or eczema that do not require systematic treatment;Hypothyroidism due to autoimmune thyroiditis requires only stable dose hormonereplacement therapy; Only a steady dose of insulin replacement is required for type 1 diabetes.

6. A history of severe allergic reactions to any monoclonal antibody and/orinvestigational drug ingredient.

7. Subjects with known active TB and suspected active TB should undergo clinicalexamination to rule out known active syphilis infection.

8. There is a history or current presence of noninfectious pneumonia/interstitial lungdisease requiring systemic glucocorticoid therapy.

9. Severe infections occurring within 4 weeks prior to first dosing, including but notlimited to active infections with comorbidification requiring hospitalization,sepsis, or severe pneumonia that received systemic anti-infective therapy within 2weeks prior to first dosing (excluding antiviral therapy for hepatitis B or C).

10. Serious medical conditions or concomitant non-oncological conditions, such asneurological disorders, psychosis, infectious diseases, or laboratory abnormalities,may increase the risk of participating in the study or taking the investigationaldrug, which the investigator believes would make the patient unfit for entry intothe study.

11. Patients with clinically significant cardiovascular disease.

12. Patients who were judged by the investigator to be unsuitable for this study.