Ovarian clear cell carcinoma
Conditions
Interventions
Experimental group:After enrollment, platinum-based chemotherapy was administered according to the type of platinum-sensitive or platinum-resistant recurrence.
Platinum-sensitive relapse: everliximab
2) Albumin paclitaxel: 260mg/m2, iv, Q3W,D1 + carboplatin: AUC=5, iv, Q3W,D1
"(According to ECOG score, as assessed by the investigator, weekly albumin-paclitaxel: 100mg/m2, iv, QW plus carboplatin: AUC=5, iv, Q3W,D1 regimen)."
Recurrent platinum-resistant: everxicumab 20mg/kg
2) albumin-paclitaxel 260mg/m2, iv,Q3W, D1 (according to ECOG PS score, assessed by the investigator, weekly albumin-paclitaxel 100mg/m2, iv, QW regimen could be used).
Sponsors
West China Second Hospital of Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Signed written informed consent; 2.Age >=18 years old, 3 months; 7.ECOG score 0-1; 8.Have sufficient organ and bone marrow function, with laboratory test values meeting the following requirements within the first 7 days of enrollment (any blood components, cell growth factors, albumin, or other corrective treatment drugs were not allowed to meet the conditions within the first 14 days of obtaining laboratory test), as follows: 1) Absolute neutrophil count (ANC) >= 1.5x10^9/L in the past 14 days without using granulocyte colony-stimulating factor, ; 2) Platelets >= 90 × 10^9/L without blood transfusion in the past 14 days; 3) Hemoglobin>9g/dL in the past 14 days without blood transfusion or use of erythropoietin; 4) Total bilirubin = 60 ml/min (calculated using Cockcroft Gault formula) ; 7) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <=1.5 × ULN; 8) Normal thyroid function that was defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) The myocardial enzyme spectrum was within the normal range (simple laboratory abnormalities that are deemed clinically insignificant by the researchers are also allowed to be included); 9.For female subjects of childbearing age, a urine or serum pregnancy test should be conducted within 3 days prior to the first administration of the study drug (Day 1 of the first cycle) and the result should be negative. If the urine pregnancy test result cannot be confirmed negative, blood pregnancy test was required. Non childbearing women was defined as postmenopausal for at least one year or have undergone surgical sterilization or hysterectomy; 10.If there was a risk of conception, all subjects (male or female) must use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy drug); 11.Provided sufficient and qualified tumor tissue samples (fresh biopsy or archived tumor tissue samples) for testing to determine the expression of tumor immune biomarkers;
Exclusion criteria
Exclusion criteria: 1.Had other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin; 2.Histological type of non clear cell carcinoma; 3.Currently participated in interventional clinical research, or had received other research drugs or used research instruments for treatment within 4 weeks before the first administration; 4.Previously received immunotherapy, including immune checkpoint inhibitors (such as anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-CD47 antibodies, anti-SIRP a antibodies, anti-LAG-3 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, any other immune mechanism of treatment; 5.Pericardial effusion with clinical symptoms required drainage; 6.History of severe bleeding tendency or coagulation dysfunction; There are clinically significant bleeding symptoms within one month before the first administration, including but not limited to gastrointestinal bleeding, coughing up blood, and nasal bleeding; 7.History of arterial and venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accidents or transient ischemic attacks, pulmonary embolism, deep vein thrombosis or any other serious thromboembolic events. Implantable venous infusion port or catheter-related thrombosis, or superficial venous thrombosis, except for those stabilized after conventional anticoagulant therapy. Allowed prophylactic usage of low dose low molecular heparin; 8.History of myocarditis, cardiomyopathy, and malignant arrhythmia. Unstable angina pectoris, myocardial infarction, congestive heart failure (NYHA grade 2 or above) or vascular disease (such as aortic aneurysm at risk of rupture) required hospitalization within 12 months prior to the first administration, or other cardiac damage that may affect the safety evaluation of the investigational drug (such as poorly controlled arrhythmias, myocardial ischemia, etc.); had a history of severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first administration ; acute exacerbation of chronic obstructive pulmonary disease occurred within one month prior to the first administration; hypertensive crisis or hypertensive encephalopathy, currently with hypertension and systolic blood pressure>150 mmHg or diastolic blood pressure>90 mmHg after oral antihypertensive medication treatment; 9.Past or current non infectious pneumonia or interstitial lung disease requiring systemic corticosteroid treatment; Active or history of clear inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea); had active autoimmune diseases that required systematic treatment within the past two years (such as drugs for improving symptoms, corticosteroids, immunosuppressants); alternative therapy was not considered a systemic treatment (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency); 10.History of immunodeficiency;positive for HIV antibodies; Currently using systemic corticosteroids or other immunosuppressants for a long time (temporary use of corticosteroids was allowed for the treatment of respiratory distress symptoms such as chronic obstr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Overall Survival;Progression Free Survival; | — |
Countries
China
Contacts
Public ContactQingli Li,xiaojuan Lin
West China Second Hospital of Sichuan University
Outcome results
None listed