It has been reported that antiangiogenic drugs combined with chemotherapy as first-line treatment, and subsequent antiangiogenic drugs as maintenance therapy for ovarian cancer can achieve better clinical benefits. Therefore, this study is expected to investigate the efficacy and safety of anlotinib combined with carboplatin/paclitaxel as first-line treatment in patients with advanced ovarian cancer.
This study is a single-arm, multicenter, exploratory phase II study to observe the efficacy and safety of anlotinib combined with carboplatin/paclitaxel as first-line treatment in patients with advanced ovarian cancer. The primary end point are progression free survival; the secondary end points include objective response rate, disease control rate, overall survival and safety. The subjects in this study: patients with newly diagnosed advanced (FIGO stage III-IV) ovarian cancer, including histologically or pathologically confirmed high-grade serous ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Anlotinib will be administered orally,once a day (12 mg) on days 1-14 of a 21-day cycle
Paclitaxel 175 mg/m2 was given intravenously for 3 hours, D1 Carboplatin AUC 5 was given intravenously for 1 hour, D1
Huai'an First People's Hospital
Huai'an, China
Nanjing Drum Tower Hospital
Nanjing, China
Zhongda Hospital Southeast University
Nanjing, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Affiliated Hospital of Jiangnan University
Wuxi, China
Yancheng No.1 People's Hospital
Yancheng, China
Progression Free Survival (PFS)
Progression Free Survival (PFS) is defined as the time from the initial treatment to disease progression (defined by RECIST 1.1) or death of any cause
Time frame: Through study completion, an average of 1-2 year
Overall Response Rate (ORR)
ORR is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as assessed by RECIST1.1
Time frame: Through study completion, an average of 1 year
Disease Control Rate (DCR)
Disease control rate is defined as the proportion of participants achieving complete response (CR), partial response (PR) or stable disease (SD) according to RECIST1.1.
Time frame: Through study completion, an average of 1 year
Overall survival (OS)
Overall survival (OS) is defined as time from randomisation to the first occurrence of death from any cause \[ Time Frame: From date of treatment beginning until the date of death from any cause
Time frame: Through study completion, an average of 1 year
Adverse events (AE)
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0 To further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in participants
Time frame: Through study completion, an average of 1 year
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