platinum-sesitive recurrence ovarian clear cell cancer
Conditions
Interventions
Experimental group:Iparomlimab and Tuvonralimab+bevazumab+TPC
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female, age >=18 years; 2. Patients with histologically confirmed ovarian clear cell carcinoma; or initially diagnosed tumor is histologically mixed, but the recurrent lesion is confirmed by histopathology to contain only clear cell carcinoma components; 3. Platinum-sensitive recurrence, i.e., recurrence occurs at least 6 months after receiving first-line platinum-containing chemotherapy; 4. At least one measurable lesion according to RECIST 1.1; 5. ECOG PS score: 0-2; 6. Expected survival greater than 3 months; 7. Main organ function is normal, and laboratory tests meet the following requirements: (1) Hemoglobin (Hb) >=9 g/dL; absolute neutrophil count (NEUT) >=1.5×10^9/L; platelet count (PLT) >=100×10^9/L; white blood cell count (WBC) >=3.0×10^9/L; (2) Creatinine clearance (CLcr) calculated by the Cockcroft-Gault equation >=50 mL/min; (3) Total bilirubin (TBIL) =50%; international normalized ratio (INR) <=1.5×ULN, activated partial thromboplastin time (APTT) <=1.5×ULN. 8. Before the first dose, any adverse events related to previous anti-tumor treatments have recovered (i.e., <=Grade 1, according to CTCAE v5.0), excluding alopecia (any grade) and <=Grade 2 peripheral sensory neuropathy, hypomagnesemia, or lymphocytopenia, and other abnormalities that, in the investigator's and/or sponsor's assessment, the benefit of treatment outweighs the risk. 9. Subjects agree to use effective contraception from the date of signing the informed consent form until 180 days after the last dose. Women of childbearing potential must not be pregnant or breastfeeding. 10. Subjects voluntarily join this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previously received treatment with immune checkpoint inhibitors (anti-PD-1/PD-L1 monoclonal antibodies or anti-CTLA-4 monoclonal antibodies), immune checkpoint agonist antibodies (such as anti-ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), or immune cell therapies. 2. Known history of allergy to macromolecular protein preparations. Contraindications or allergies to any components of ipalimumab, bevacizumab, or chemotherapy drugs. 3. Use of full-dose oral or injected anticoagulants or thrombolytic agents for treatment purposes within 10 days before the start of study treatment (prophylactic use of low-dose aspirin, low molecular weight heparin, and rivaroxaban is allowed). 4. Presence of conditions requiring systemic use of corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-a inhibitors, etc.) within 2 weeks before the first dose. Local use of corticosteroids, nasal sprays, and inhaled steroids is allowed. Systemic corticosteroids are allowed for the prevention of contrast agent allergy. 5. Active or potentially recurrent autoimmune diseases, except for the following: vitiligo, alopecia, psoriasis, or eczema that does not require systemic treatment; hypothyroidism caused by autoimmune thyroiditis that only requires stable-dose hormone replacement therapy; type 1 diabetes that only requires stable-dose insulin replacement therapy. 6. History of gastrointestinal perforation and/or fistula, intestinal obstruction (subjects with incomplete obstruction or obstruction symptoms/signs at initial diagnosis may be treated and enrolled after symptom resolution as assessed by the investigator), extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea within 6 months before the first dose. 7. Symptomatic, untreated, or clinically unstable brain metastases or leptomeningeal metastases; 8. History of interstitial lung disease and/or pneumonia or pulmonary hypertension. 9. Hypertension (systolic >150 mmHg and/or diastolic >100 mmHg) and diabetes poorly controlled despite standard treatment, uncontrolled or symptomatic arrhythmia. 10. Thrombotic or embolic events within 6 months prior to study treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction) or pulmonary embolism. 11. Myocardial infarction within the past 12 months, severe/unstable angina, symptomatic congestive heart failure (NYHA class III or IV). 12. Drainage of ascites, pleural effusion, or pericardial effusion within 4 weeks prior to enrollment. 13. Severe, unhealed, or dehisced wounds and active ulcers or untreated fractures. 14. Other concurrent active malignancies, excluding malignancies in remission for more than 5 years or carcinoma in situ deemed cured with appropriate treatment. 15. Known active HIV, HBV, or HCV infection. 16. Major surgery (excluding puncture biopsy) within 4 weeks prior to first dose and not fully recovered. 17. Other conditions deemed by the investigator as unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;safety;overall survival;disease control rate; | — |
Countries
China
Contacts
Public ContactLingfang Xia
Fudan University Shanghai Cancer Center
Outcome results
None listed