advanced epithelial ovarian
Conditions
Interventions
Treatment:Iparomlimab and tuvonralimab antibody combined with TC
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily join this study, sign informed consent, and have good compliance; 2. FIGO stage is stage IIIC-IV newly diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer; 3. Those who are judged by a professional gynecologic oncologist designated by the center to be difficult to achieve R0 resection or unable to tolerate primary debulking surgery, including but not limited to: Stage IIIC Fagotti score >= 8; Stage IV patients; Those with a stage IIIC Fagotti score of = 1.5×10^9/L, platelet >= 100×10^9/L, hemoglobin >= 90g/L, aspartate base transferase (AST) and alanineyltransferase (ALT) <= 2.5× upper limit of normal (ULN) (<= 5 × ULN in patients with liver metastases) or alkaline phosphatase <= 2.5 × ULN (or 5× ULN in =the case of liver metastases or bone metastases), total bilirubin <= 1.5×ULN, serum creatinine <= 1.5×ULN; 9. Subjects of potential childbearing potential who need to use at least one medically approved form of contraception (such as intrauterine device, birth control pills, or condoms) during study treatment and for 180 days after the end of study treatment; and must have a negative serum/urine HCG test before the first dose; and must be non-lactating.
Exclusion criteria
Exclusion criteria: 1. Histopathology for mucinous adenocarcinoma, low-grade serous adenocarcinoma; 2. Known hypersensitivity to any of the drugs in the study; 3. Active autoimmune disease requiring systemic therapy within 2 years prior to initiation of study treatment, or in the judgment of the investigator, presence of autoimmune disease that may relapse or is planned for treatment. Exceptions include: skin conditions that do not require systemic treatment (e.g., vitiligo, alopecia, psoriasis, or eczema); 1.Hypothyroidism due to autoimmune thyroiditis requiring only stable doses of hormone replacement therapy; 2.Type I diabetes mellitus requiring only a stable dose of insulin replacement therapy; 3.Childhood asthma has been completely relieved and no intervention is required in adulthood; 4.The disease judged by the investigator to be unlikely to recur in the absence of external triggers; 4. Subjects requiring systemic treatment with glucocorticoids (>10 mg/day prednisone equivalent) or other immunosuppressive drugs within 14 days prior to the first dose. Exceptions are made to the following: If there is no active autoimmune disease, treatment with inhaled, ophthalmic, or topical glucocorticoids or other glucocorticoids at doses not exceeding 10 mg/day of prednisone or equivalent doses is permitted. 5. Active infection requiring systemic therapy; 6. History of severe cardiovascular and cerebrovascular diseases: cerebrovascular accident (excluding lacunar cerebral infarction, mild cerebral ischemia or transient ischemic attack, etc.), myocardial infarction, unstable angina, and poorly controlled arrhythmias (including QTc interval >= 450 ms for men and >= 470 ms for women) within 6 months before the first dose of the study drug (QTc interval is calculated by Fridericia's formula); 5.New York Heart Association (NYHA) cardiac function class > class II or left ventricular ejection fraction (LVEF) = 2000 IU/ml or 104 copies/ml; 6.HCV antibody positive and HCV viral copy number > upper limit of normal); 10. Diagnosis of any other malignancy within 3 years prior to enrollment (except for various carcinoma in situ [such as breast cancer, bladder cancer, carcinoma in situ of the cervix] or basal cell carcinoma or squamous cell carcinoma of the skin that have received potentially curative therapy); 11. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 12. HIV-positive; 13. Symptomatic brain metastases (confirmed or suspected); 14. In the opinion of the investigator, the subject has any clinical or laboratory examination abnormalities or other reasons that make it unsuitable to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection;CRS 3;objective response rate;disease control rate;progression-free survival;overall survival;safety;exploratary endpoint; | — |
Countries
China
Contacts
Public ContactGuonan Zhang
Sichuan Cancer Hospital
Outcome results
None listed