Advanced recurrent ovarian cancer
Conditions
Interventions
Group A:6 cycles of bevacizumab IBI305 combined with platinum-containing doublet chemotherapy followed by 16 cycles of bevacizumab IBI305 maintenance therapy
Group B:Bevacizumab in combination with non-platinum chemotherapy
Sponsors
The Second People's Hospital of Anhui Province
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form. 2. Histologically confirmed epithelial ovarian or fallopian tube cancer or primary peritoneal cancer. 3. Entry criteria for different cohorts: (1) Cohort A: Patients with advanced ovarian cancer who had not previously received systemic therapy or had platinum-sensitive recurrence. (2) Cohort B: Patients with platinum-resistant relapsed ovarian cancer (who had previously received one platinum-containing systemic therapy and had disease progression during or after systemic therapy. Patients were considered to have received first-line therapy if they progressed or relapsed during or within 6 months of neoadjuvant or adjuvant chemotherapy with platinum-based regimens). 4. Females aged >= 18 years. 5. Expected survival time >= 12 weeks. 6. At least 1 measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). 7. According to the Eastern Cooperative Oncology Group performance status score (ECOG PS score) 0-2 points. 8. Having adequate organ and bone marrow function, as defined below: (1) Blood routine: absolute neutrophil count >= 1.5x10^9/L; platelet count >= 100x10^9/L; hemoglobin content >= 9.0 g/dL. (2) Liver function: serum total bilirubin (TBIL) = 50 mL/min; urine dipstick test results show urine protein <2+. (4) Coagulation function: activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5xULN.
Exclusion criteria
Exclusion criteria: 1. Received live attenuated vaccine within 4 weeks before enrollment or planned during the study. 2. Active, known or suspected autoimmune disease. 3. Known history of primary immunodeficiency. 4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation (patients in cohort C). 5. Pregnant or breastfeeding female patients. 6. Untreated acute or chronic active hepatitis B or C infection. For patients receiving antiviral therapy, under the condition of monitoring the number of virus copies, doctors will judge whether they are eligible for inclusion according to the individual conditions of the patients. 7. Uncontrolled concurrent diseases, including but not limited to: (1) HIV-infected patients (HIV antibody positive). (2) Serious infection in active stage or poorly controlled clinically. (3) Evidence of severe or uncontrolled systemic disease (eg severe psychiatric, neurological disease, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, hepatic or renal disease, uncontrolled hypertension [i.e. greater than or equal to CTCAE 2 grade hypertension]). (4) Those with active bleeding or new thrombotic disease who are taking therapeutic anticoagulant drugs or have a tendency to bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactCheng Xianping
The Second People's Hospital of Anhui Province
Outcome results
None listed