- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03393507
A Study of Apatinib Treatment in for Advanced Ovarian Cancer
A Study of Apatinib in Combination With Chemotherapy Versus Chemotherapy Alone for Advanced Ovarian Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Xuan Zhang, MDB
- Phone Number: 8618990631232
- Email: 79916363@qq.com
Study Locations
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Sichuan
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Leshan, Sichuan, China, 600000
- Recruiting
- Zhang xuan
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Contact:
- Zhang Xuan, MD
- Phone Number: 861890631232
- Email: 79916363@qq.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pathologically diagnosed as epithelial ovarian cancer, fallopian tube cancer, stage II-IV period, the expected survival of> 6 months;
- ECOG <2;
- Liver and kidney function is normal;
- No uncontrollable high blood pressure, bleeding, perforation, obstruction.
Exclusion Criteria:
- Serious cardiopulmonary insufficiency, can not tolerate chemotherapy;
- Pregnant or lactating women;
- 3 years have occurred in other tumors (cervical cancer in situ, has cured basal cell carcinoma, except for bladder epithelial tumors);
- Allergic to apatinib or its accessories.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: chemotherapy
|
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.
|
Experimental: apatinib combine with chemotherapy
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500mg,po, adjusted to 250mg if cannot tolerate, 3 weeks a cycle for a total of 6 cycles
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS(Progress free survival)
Time Frame: 24 month
|
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.
|
24 month
|
carcinoma antigen 125 (CA125)
Time Frame: 24month
|
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.
|
24month
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Apatinib
Other Study ID Numbers
- LS-OV-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Cancer
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
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Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
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Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
University of WashingtonMinnesota Ovarian Cancer AllianceTerminatedStage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage IVA Ovarian Cancer AJCC v8 | Stage IVB Ovarian... and other conditionsUnited States
Clinical Trials on Apatinib
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Elevar TherapeuticsCompletedAdenoid Cystic CarcinomaUnited States, Korea, Republic of
-
Shanghai Jiao Tong University Affiliated Sixth...UnknownSoft Tissue Sarcoma
-
Tianjin Medical University Cancer Institute and...Unknown
-
Peking University Cancer Hospital & InstituteRecruiting
-
Wuhan Union Hospital, ChinaWithdrawnColorectal Cancer | Chemotherapy | Angiogenesis
-
Tianjin Medical University Second HospitalJiangsu HengRui Medicine Co., Ltd.Unknown
-
Lei LiCompletedChemotherapy | Recurrent Cervical Carcinoma | Apatinib | Targeted Therapy | Persistent Advanced Cervical Carcinoma | Vascular Endothelial Growth Factor 2 InhibitorChina
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The First Affiliated Hospital of Zhengzhou UniversityRecruitingEsophageal Cancer by AJCC V8 StageChina
-
Peking UniversityJiangsu HengRui Medicine Co., Ltd.Recruiting