Apatinib With Albumin-bound Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer
- Registration Number
- NCT03942068
- Lead Sponsor
- Henan Cancer Hospital
- Brief Summary
The study was designed to evaluate the efficacy and safety of apatinib with albumin-bound paclitaxel in patients with platinum-resistant recurrent ovarian cancer.
- Detailed Description
The study is an open, one-arm, prospec will collect 35 patients with platinum-resistant recurrent ovarian cancer treated with apatinib with albumin-bound paclitaxel from 2019 to 2020 in Henan Cancer Hospital.Antiangiogenic treatments have been implicated to play a major role in ovarian cancer (OC). Apatinib, a novel oral antiangiogenic agent targeting vascular endothelial growth factor receptor (VEGFR2), in combination with weekly paclitaxel, may improve clinical outcomes compared with apatinib or paclitaxel alone in patients with refractory or platinum-resistant ovarian cancer.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 35
- Female, age ≥18 years and ≤70 years, signed informed consent.
- Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy).
- At least treated with one line of platinum-based chemotherapy.
- Imaging confirmed diagnosis of progression occurred after the last treatment before enrollment.
- Histologically or pathologically confirmed diagnosis of ovarian cancer as primary tumor.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Patients must have a life expectancy of at least 3 months.
- Patients must have adequate organ function as defined by the following criteria:
- White blood cell count ≥ 3 x 10^9/L, Absolute neutrophil count (ANC) (≥ 1.5 x 10^9/L), Hemoglobin of ≥ 80 g/L, Platelets ≥ 70 x 10^9/L, Total bilirubin ≤ 1 x upper limit of normal (ULN), AST and ALT ≤ 2 x ULN, Serum creatinine ≤ 1 x ULN.
-
1.Had prior exposure to apatinib or has known allegies to any of the excipients.
2.Patients with trauma, surgical history, gastrointestinal bleeding, and melena within 1 month prior to treatment.
3.Inadequately controlled hypertension. 4.History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1.
5.Imaging studies suggest that patients with tumors invading important blood vessels.
6.Symptomatic central nervous system (CNS) metastasis. 7.History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description albumin-bound paclitaxel+apatinib albumin-bound paclitaxel albumin-bound paclitaxel:260mg/m2，q3w，d1 apatinib:500mg，qd，po albumin-bound paclitaxel+apatinib Apatinib albumin-bound paclitaxel:260mg/m2，q3w，d1 apatinib:500mg，qd，po
- Primary Outcome Measures
Name Time Method ORR Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months Objective Response Rate
- Secondary Outcome Measures
Name Time Method PFS through study completion, an average of 5 year Progression-Free Survival
OS through study completion, an average of 5 year Overall Survival
DCR Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months Disease Control Rate