- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03942068
Recruitment Status Not yet recruiting
First Posted May 8, 2019
Last update posted May 8, 2019
The study was designed to evaluate the efficacy and safety of apatinib with albumin-bound paclitaxel in patients with platinum-resistant recurrent ovarian cancer.
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.
|Experimental: albumin-bound paclitaxel+apatinib
albumin-bound paclitaxel:260mg/m2，q3w，d1 apatinib:500mg，qd，po
Drug: albumin-bound paclitaxel
Nanoparticle albumin-bound paclitaxel (nab-paclitaxel), a microtubule inhibitor
a novel oral antiangiogenic agent targeting vascular endothelial growth factor receptor (VEGFR2)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
1. Female, age ≥18 years and ≤70 years, signed informed consent.
2. 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).
3. At least treated with one line of platinum-based chemotherapy.
4. Imaging confirmed diagnosis of progression occurred after the last treatment before
5. Histologically or pathologically confirmed diagnosis of ovarian cancer as primary
6. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
8. Patients must have a life expectancy of at least 3 months.
9. Patients must have adequate organ function as defined by the following criteria:
10. 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.
Henan Cancer Hospital