Ovarian Cancer
Conditions
Interventions
Experimental group:Using carrilizumab 200mg Q3W Preoperative neoadjuvant therapy + postoperative adjuvant therapy + maintenance therapy
Sponsors
The Obstetrics & Gynecology Hospital of Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed high-grade serous adenocarcinoma of the ovaries, fallopian tubes, and primary peritoneum; 2) Screening of patients with high expression of PD-L1 and CXCL13 (CPS >= 1) and TLS count >= 1 using immunohistochemistry method in primary lesion biopsy; 3) Researchers evaluate suitability for receiving this treatment; 4) Clinical stage IIIC/IV and inability to perform satisfactory initial tumor reduction surgery; 5) ECOG 0-1 level; Expected lifespan>3 months; 6) Age range: 18-75 years old; 7) No history of severe allergies; 8) Hemoglobin >= 90 g/L, WBC >= 3.5 × 10^9/L, neutrophil ANC >= 1.5 × 10^9/L, platelets >= 100 × 10^9/L; Cr <= 1.5 × ULN (normal upper limit), TBIL <= 1.5 × ULN; AST and ALT <= 2.5 × ULN, international standardized ratio INR or plasma prothrombin time PT <= 1.5 × ULN; 9) The patient voluntarily participates, fully understands and is able to sign an informed consent form; Willing to follow and capable of completing all experimental procedures.
Exclusion criteria
Exclusion criteria: 1) Histologically diagnosed with other pathological types such as ovarian clear cell carcinoma, low-grade serous adenocarcinoma, endometrioid carcinoma, mucinous adenocarcinoma, or carcinosarcoma; 2) Primary malignant tumors with activity in other parts of the body, except for the following situations: a cured malignant tumor with no known active disease for = 5 years before the first administration of IP, and a low potential risk of recurrence; Fully treat non melanoma skin cancer or malignant nevi without any signs of disease; Fully treated carcinoma in situ with no signs of disease; 3) Has received treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, or anti-CTLA-4 antibody, etc; 4) Has received treatment with anti VEGF antibodies, etc; 5) Individuals who are allergic to any known test drug ingredients; 6) Pregnant or lactating patients; 7) Previous thyroid dysfunction and inability to maintain normal thyroid function despite medication treatment; 8) Patients who need to receive systemic corticosteroids (doses equivalent to or higher than 10mg/d prednisone) or other immunotherapy drugs 14 days before enrollment or during the study period; 9) Suffering from active autoimmune diseases and requiring systemic treatment within the past 2 years; 10) Those who have received live vaccination within 4 weeks of the start of treatment, or those who have received anti-tumor vaccines; 11) Known history of human immunodeficiency virus (HIV) infection or other acquired or congenital immunodeficiency patients; 12) Patients with a known history of hepatitis B or known active hepatitis C virus infection and syphilis; 13) Have a known history of active tuberculosis (TB; tubercle bacillus).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival,PFS;Objective Response Rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival,OS;Duration of remission ,DOR;Disease control rate,DCR;time to treatment failure,TTP;Adverse events occurred during treatment,AEs; | — |
Countries
China
Contacts
Public ContactJiaqi Lu; Wei Jiang
The Obstetrics & Gynecology Hospital of Fudan University
Outcome results
None listed