ovarian cancer
Conditions
Interventions
Regimen group 1:Arsenic trioxide (ATO) + albumin paclitaxel weekly + 5-fluorouracil + bevacizumab
Regimen group 2:Arsenic trioxide (ATO) + albumin paclitaxel + 5-fluorouracil + liposomal doxorubicin + bevacizumab
Control group:Liposomal doxorubicin plus bevacizumab
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily participated in this study and signed the informed consent; 2. women aged >=18 years; 3. Recurrent/refractory ovarian cancer, primary fallopian tube cancer or primary peritoneal cancer; 4. Relapse within 6 months after completion of the last platinum-based chemotherapy or disease progression during chemotherapy (i.e., platinum-resistant relapse or platinum-refractory); 5. ECOG score 0 or 1, predicted survival time not less than 4 months; 6. had measurable or non-measurable lesions according to RECIST 1.1; 7. The main organ function is good, and the examination indicators within 14 days before enrollment meet the following requirements: 1) Blood routine examination (no blood transfusion within 14 days) : a. hemoglobin (Hb) >=80 g/L; b. Neutrophil count (ANC) >=1.5×10^9/L; c. Platelet count (PLT) >=80×10^9/L; 2) Biochemical tests: a. Total bilirubin = 60mL/min (Cockcroft-Gault formula); 3) Doppler echocardiography: left ventricular ejection fraction (LVEF)>= the lower limit of normal (50%); 8. The interval between the first dose of the trial drug and the end of the previous chemotherapy, radiotherapy, targeted therapy, immunotherapy or other anti-tumor treatment should be more than 4 weeks. 9. Women of childbearing age had to consent to use a highly effective method of contraception for the duration of the study and for 6 months after the last dose of study drug; A negative serum or urine pregnancy test within 7 days before study entry and must be non-lactating.
Exclusion criteria
Exclusion criteria: 1. Known to be allergic to the active or inactive components of arsenicals; 2. Comorbidities/medical history (1) Clinically significant hemoptysis (> 50ml/day) within 3 months before enrollment; Or clinically significant bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood or above, or angiitis; (2) arteriovenous thrombosis events occurred within 6 months before randomization, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except those who had been cured by the investigator's assessment due to venous catheterization caused by previous chemotherapy), and pulmonary embolism; (3) hypertension that is not well controlled by antihypertensive medication (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg); Within 6 months before randomization, myocardial infarction, severe or unstable angina, NYHA class 2 or higher cardiac dysfunction, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure occurred; (4) Interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases (such as diabetes mellitus, pulmonary fibrosis and acute pneumonia); (5) Renal insufficiency: urinary protein >= ++ or 24-hour urinary protein >=1.0g; (6) a history of vaccination with live attenuated vaccine within 28 days before the first dose of study medication or an expected vaccination with live attenuated vaccine during the study period; (7) human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); Active hepatitis (hepatitis B, defined as HBV-DNA >= 500 IU/ml; Hepatitis C, defined as HCV-RNA higher than the lower detection limit of the analytical method) or co-infection with hepatitis B and C; (8) Severe infection within 4 weeks before the first dose, including but not limited to bacteremia requiring hospitalization and severe pneumonia; Active infection of CTCAE grade >=2 requiring treatment with systemic antibiotics within 2 weeks before the first dose or unexplained fever >38.5°C during screening or before the first dose (fever due to cancer, as judged by the investigator, was eligible); Evidence of active tuberculosis infection within 1 year before administration; (9) any other malignant tumor diagnosed within 3 years before study entry, except adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ; (10) patients received palliative radiotherapy with >20% bone marrow one week before enrollment; Patients had a previously or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 11. Major surgery within 28 days before randomization (diagnostic biopsy and peripherally inserted central catheter [PICC] procedures were permitted); (12) subjects who had received or prepared to receive allogeneic bone marrow transplantation or solid organ transplantation; (13) peripheral neuropathy >= grade 2; Patients with active brain metastases, cancer meningitis, spinal cord compression, or brain or leptomeningeal disease on screening imaging CT or MRI (patients with symptomatic stable brain metastases who had completed treatment 14 days before enrollment were eligible if they had no signs of cerebral hemorrhage as confirmed by evaluation of brain MRI, CT, or venography). 3. Current or recent (within 30 days before enrollment) use of another trial drug or participat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Overall survival;Objective response rate; | — |
Countries
China
Contacts
Public ContactLi Xiaoping
Peking University People's Hospital
Outcome results
None listed