Ovarian cancer
Conditions
Interventions
Test group:Sintilimab+Albumin-bound paclitaxel+Doxorubicin liposome+Etoposide
Sponsors
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Eligible subjects for this study must meet all of the following criteria: 1. Sign a written informed consent form before any study-related procedures are performed. 2. Female patients aged >= 18 years and 3 months. 9. Adequate organ function, as evidenced by the following laboratory values: 1) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L within 14 days without granulocyte colony-stimulating factor. 2) Platelet count >= 100 x 10^9/L within 14 days without blood transfusion. 3) Hemoglobin > 9 g/dL within 14 days without blood transfusion or erythropoietin. 4) Total bilirubin 1.5 x ULN but direct bilirubin = 60 ml/min. 7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 x ULN. 8) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. Subjects with baseline TSH outside the normal range but with total T3 (or FT3) and FT4 within the normal range are also eligible. 9) Normal cardiac enzyme levels (subjects with non-clinically significant isolated laboratory abnormalities as determined by the investigator are also eligible); (optional) 10. For female subjects of childbearing potential, a negative urine or serum pregnancy test must be obtained within 3 days before the first administration of the study drug (Day 1 of Cycle 1). If the urine pregnancy test result is inconclusive, a serum pregnancy test is required. Postmenopausal women are defined as those who have been amenorrheic for at least 1 year, have undergone surgical sterilization, or have had a hysterectomy. 11. If there is a risk of conception, all subjects (regardless of gender) must use a contraceptive method with a failure rate of less than 1% per year throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy).
Exclusion criteria
Exclusion criteria: Subjects meeting the following criteria are not eligible for this study: 1. Diagnosed with any malignant disease other than ovarian cancer within 5 years prior to the first dose administration (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or carcinoma in situ that have been treated with radical resection); 2. Currently participating in an interventional clinical research treatment, or have received other investigational drugs or used investigational devices within 4 weeks prior to the first dose administration; 3. Have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.); 4. Have received systemic treatment with traditional Chinese medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks prior to the first dose administration; 5. Have had an active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose administration. Alternative therapies (e.g., thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment; 6. Are receiving systemic glucocorticoid treatment (excluding nasal sprays, inhalation, or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose administration of the study. Note: Physiological doses of glucocorticoids (=10 mg/day of prednisone or equivalent) are allowed; 7. Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Known hypersensitivity to the active ingredient or excipients of the study drug, sintilimab; 9. Have not fully recovered from any toxicity and/or complications caused by any intervention measures (i.e., <= grade 1 or back to baseline, excluding fatigue or alopecia) before starting treatment; 10. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 11. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number greater than the upper limit of normal value of the laboratory in the research center); Note: Subjects with hepatitis B meeting the following criteria may also be enrolled: 1) HBV viral load < 1000 copies/ml (200 IU/ml) before the first dose administration, and the subject should receive anti-HBV treatment throughout the study drug treatment period to prevent viral reactivation; 2) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), no preventive anti-HBV treatment is required, but close monitoring of viral reactivation is necessary; 12. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the detection limit); 13. Have received a live vaccine within 30 days before the first dose administration (Cycle 1, Day 1); Note: Subjects are allowed to receive inactivated virus vaccine for seasonal influenza by injection within 30 days before the first dose administration; however, intranasal live attenuated influenza vaccine is not allowed; 14. Pregnant or lactating women; 15. Have any severe or uncontrolled systemic diseases, such as: 1) Major and symptomatic severe and d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival period;Disease control rate;Duration of response;Overall survival ;AEs; | — |
Countries
China
Contacts
Public ContactLiang Chen
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Outcome results
None listed