Ovarian cancer
Conditions
Interventions
Experimental Group:Iparomlimab and Tuvonralimab combined with Senaparib
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years old (including the boundary value), female; 2. Newly diagnosed high-grade serous carcinoma, fallopian tube carcinoma or peritoneal carcinoma confirmed by histological pathology, with a stage belonging to the 2018 International Federation of Obstetricians and Gynecologists (FIGO) stage III to IV; 3. It does not meet the indications for the initial cytoreductive surgery and plans to perform maximum cytoreductive surgery on tumor cells during intermittent cytoreductive surgery. 4. Meet the indications for neoadjuvant therapy; 5. ECOG score: 0-1 point; 6. Expected survival period >=12 weeks; 7. Normal functions of major organs, meeting the following criteria: Neutrophil count ANC>=1.5 x 10^9/L, platelet count >=100 x 10^9/L, hemoglobin >=100g/L, total bilirubin <=1.5×ULN; ALT and AST<3×ULN; Creatinine <=1.5×ULN; 8. Agree to provide tumor tissue samples for biomarker detection; If there are not enough tumor tissue samples, they can be enrolled only after obtaining the consent of the researcher. 9. Voluntarily sign the informed consent form and be able to understand and comply with the research requirements to complete the study
Exclusion criteria
Exclusion criteria: 1. Known allergy to the investigational drug or any of its excipients; 2. Major surgery (involving removal of at least one organ, including ovaries) within 28 days prior to the first dose; 3. History of other malignancies within the past 5 years, except for malignancies that have been cured with no recurrence; 4. Patients with active brain metastases; 5. Patients with other serious concurrent illnesses, such as extensive interstitial lung disease requiring medication, active or uncontrolled infections (e.g., tuberculosis, HIV), decompensated liver disease, active hepatitis, active bleeding; patients with a history of cerebrovascular accident or pulmonary embolism; active, known, or suspected autoimmune diseases; active infection requiring systemic anti-infective therapy; 6. Use of immunosuppressive drugs or systemic corticosteroids for immunosuppression (prednisone or equivalent at a dose of >10 mg/day) within 2 weeks prior to administration; 7. Use of herbal medicines with anti-tumor effects or immunomodulatory drugs (such as thymidine, interferon, interleukin-2) within 2 weeks prior to the trial; 8. Administration of live attenuated vaccines within 4 weeks prior to Cycle 1 Day 1 or anticipated need for such vaccines during the study; 9. Uncontrolled other diseases or comorbidities; 10. Pregnant women, women planning for pregnancy, and lactating women; 11. Other situations considered inappropriate for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in peritoneal cancer index score ;Changes in CA125 levels ;R0 resection rate ;Pathologic complete response;Progression free survival;Overvall sruvival; | — |
Countries
China
Contacts
Public ContactZhang Zhengmao
The Fourth Hospital of Hebei Medical University
Outcome results
None listed