A Phase 2 interventional study of Apatinib and Taxus + platinum in Ovarian Cancer and Chemotherapeutic Toxicity, sponsored by The People's Hospital of Leshan. Status unknown at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-01-16.
Sponsored by The People's Hospital of Leshan · Phase 2, Interventional, and Treatment
The study is evaluated the effacy and safety of apatinib combined with chemotherapy in the advanced ovarian cancer
Ovarian cancer and fallopian tube cancer are common gynecological malignancies in our country. Ovarian cancer ranks the second in the incidence of gynecologic malignancies. The mortality rate is the highest. The following three major characteristics exist: First, 70% of the patients are advanced patients; 70% of the patients Easy to relapse after treatment; Third, 5-year survival rate of about 30%, a serious threat to women's health. Our hospital ovarian cancer, tubal cancer patients because of regional constraints, the economy is poor, the more the past, the use of simple chemotherapy, relapse rate and mortality were higher.
In the latest National Comprehensive Cancer Network (NCCN) guidelines, bevacizumab plus CP is recommended for patients with stage II, III, and IV ovarian cancer and fallopian tube cancer, and clinical trials of new drugs are recommended for recurrent / metastatic ovarian cancer. Apatinib mesylate is a small molecule VEGFR tyrosine kinase inhibitor authored by Jiangsu Hengrui Pharmaceutical Co., Ltd., whose chemical name is N- [4- (Cyanocyclopentyl) phenylmethane sulfonate ] [2 - [(4-picolyl) amino] (3-pyridyl)] carboxamide of the formula C25H27N5O3S with a molecular weight of 493.58 (mesylate salt).Apatinib can effectively inhibit VEGFR-2 at a very low concentration, while higher concentrations can inhibit the action of apatinib, such as platelet-derived growth factor receptor (PDGFR), c-Kit and c- The site is the intracellular ATP binding site of the protein tyrosine receptor. Pharmacodynamic studies show that apatinib can inhibit the VEGFR-2 tyrosine kinase activity, blocking VEGF signaling after binding, resulting in inhibition of tumor angiogenesis. Preclinical studies have shown that apatinib has a strong inhibitory effect on the growth of many human nude mice xenografts such as sarcoma, colorectal cancer, non-small cell lung cancer, gastric cancer and liver cancer and is a broad-spectrum anti-tumor drug.
3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.
This study's planned enrollment of 34 is below the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →This is the only study on the registry with The People's Hospital of Leshan as lead sponsor.
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The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
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A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
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Histologically or cytologically confirmed
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Your pathology report is the document that shows this.
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ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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Drug: Apatinib · Drug: Taxus + platinum
Drug: Taxus + platinum
500mg,po, adjusted to 250mg if cannot tolerate, 3 weeks a cycle for a total of 6 cycles
Drug pages: Paclitaxel · Platinum Compounds
Taxanes are paclitaxel or docetaxel, and platinum is carboplatin or cisplatin. Docetaxel injection dose size of 60-75mg / m2, infusion time of 1 hour; paclitaxel injection dose size 135-175mg / m2, infusion time\> 3 hours; injection of carboplatin dose according to the standard formula Calculated, AUC = 4-5, continued intravenous infusion the next day; cisplatin injection dose size of 75-100mg / m2.
PFS(Progress free survival)
he length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Time frame: 24 month
carcinoma antigen 125 (CA125)
Cancer antigen 125 (CA-125) is a protein found on the surface of many ovarian cancer cells. It also can be found in other cancers and in small amounts in normal tissue. A CA-125 test measures the amount of this protein in the blood.
Time frame: 24month
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2017 (actual). Primary completion is estimated for Dec 2018, 16 months after the start.
Of 228 non-industry phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 80. This study's planned 16 months is below that.
Counting every sponsor, half of 344 studies reached it within 47 months; a quarter within 33 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Apatinib