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- Klinische proef NCT03144843
Apatinib Combined With Paclitaxol as Second Line Therapy for Advanced Gastric Cancer.
A Phase II Multicenter, Randomized, Double-blind Study of Apatinib Combined With Paclitaxol Versus Placebo With Paclitaxol as Second Line Therapy for Advanced Gastric / Esophagogastric Junction Adenocarcinoma With Peritoneal Metastasis.
This multicenter, randomized, double-blind study will evaluate the efficacy and safety of apatinib combined with paclitaxol versus placebo combined with paclitaxol in advanced gastric cancer or gastroesophageal junction carcinoma patients with peritoneal metastasis.
Patients will be randomized to one treatment arm: Arm A: apatinib 500mg qd, Paclitaxol 80mg/m2, d1, d8, d15,every 4 weeks ; Arm B: placebo 500mg qd, Paclitaxol 80mg/m2, d1, d8, d15,every 4 weeks ; Tumor assessment will be done every 8 weeks according to RECIST 1.1. The primary endpoint is progression free survival (PFS).
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Gastric cancer is the second most common cause of cancer-related deaths worldwide, and most patients are diagnozed at advanced stage in China. Peritoneal metastasis is the most common metastatic site. For gastric cancer patients with peritoneal metastasis, chemotherapy can bring survival benefit versus best sportive care. Paclitaxol is the standard second line chemotherapy for advanced gastric cancer patients.
Apatinib mesylate is a small-molecule vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor (TKI). It has been approved as third-line treatment for patients with advanced gastric adenocarcinoma in China.
This multicenter, randomized, double-blind study will evaluate the efficacy and safety of apatinib combined with paclitaxol versus placebo combined with paclitaxol in advanced gastric cancer or gastroesophageal junction carcinoma patients with peritoneal metastasis.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Guangdong
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Foshan, Guangdong, China
- Werving
- Foshan people's Hospital
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Contact:
- Wei Wang
- Telefoonnummer: 075783161035
- E-mail: m18038863618@163.com
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Guangzhou, Guangdong, China, 510060
- Werving
- Cancer center of Sun Yat-sen University
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Contact:
- Miao-Zhen Qiu, MD, PhD
- Telefoonnummer: 86-020-87342490
- E-mail: qiumzh@sysucc.org.cn
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Contact:
- Fenghua Wang, MD, PhD
- Telefoonnummer: 86-020-87342490
- E-mail: wangfh@sysucc.org.cn
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Adult patients, aged between 18 and 75 years old;
- Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ;
- At least one measurable and evaluable disease based on response evaluation criteria in solid tumors (RECIST v1.1); and confirmed as peritoneal metastasis by CT scan or laparoscope
- Patients must have received one prior chemotherapy regimen for AGC;First-line therapy must have included a combination of at least a platinum-based treatment given concurrently, and must have experienced disease progression during or after first-line therapy for their disease;
- Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
- Life expectancy of more than 3 months;
- Duration from the last therapy is more than 6 weeks for nitroso or mitomycin, More than 4 weeks for other cytotoxic agents, operation or radiotherapy;
- Adequate hepatic, renal, heart, and hematologic functions ( hemoglobin≥ 90g/L, platelets ≥ 80 × 10*9/L, neutrophil ≥1.5 × 10*9/L, serum creatinine≤ 1.5mg/dl, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN)
Exclusion Criteria:
- Pregnant or lactating women;
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;
- Prior chemotherapy regimen have included taxane (docetaxel or paclitaxel); 4. Uncontrolled hypertension;
5. Intercurrence with one of the following: coronary artery disease, arrhythmia and heart failure; 6. Urine protein>grade 1; 7. Any factors that influence the usage of oral administration; 8. Patients with a clear tendency of gastrointestinal bleeding; 9. Abnormal coagulation function(INR≥1.5, APTT≥1.5 ULN); 10. Abuse of alcohol or drugs; 11. Less than 4 weeks from the last clinical trial; 12. Prior treatment with antivascular endothelial growth factor or the other anti angiogenesis therapy; 13. Evidence of central nervous system(CNS) metastasis; 14. Disability of serious uncontrolled intercurrence infection.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Experimental group
Apatinib: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks
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Apatinib 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks
Andere namen:
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Placebo-vergelijker: Placebo group
Placebo: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks
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Placebo: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Progression-free survival (PFS)
Tijdsspanne: Approximately 1 year
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The time from randomize to progression or death
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Approximately 1 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Overall survival (OS)
Tijdsspanne: Approximately 3 years
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The time from randomize to death
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Approximately 3 years
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Objective response rate (ORR)
Tijdsspanne: Approximately 1 year
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The rate of complete response and partial response according to RECIST guidelines
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Approximately 1 year
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Disease control rate(DCR)
Tijdsspanne: Approximately 1 year
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The rate of complete response , partial response and stable disease according to RECIST guidelines
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Approximately 1 year
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Safety (incidence of adverse events) [
Tijdsspanne: Approximately 1 year
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Incidence of adverse events
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Approximately 1 year
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata
- Neoplasmata per site
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Maag Ziekten
- Maagneoplasmata
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Proteïnekinaseremmers
- Apatinib
Andere studie-ID-nummers
- Apatinib_GC
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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Klinische onderzoeken op Maagkanker
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RSP Systems A/SVoltooid
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Medtronic - MITGVoltooid
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State University of New York - Upstate Medical...BeëindigdGastric Bypass-statusVerenigde Staten
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Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)IngetrokkenGastric Bypass-operatie
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Olympus Corporation of the AmericasUnity Health TorontoVoltooid
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaVoltooidRoux en Y Gastric BypassVerenigde Staten
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North Dakota State UniversityNational Institutes of Health (NIH)VoltooidRoux en Y Gastric Bypass ChirurgieVerenigde Staten
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaVoltooidSleeve gastrectomie | Roux en Y Gastric BypassVerenigde Staten
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Medical University of South CarolinaVoltooidGastric Bypass Chirurgie PijnbestrijdingVerenigde Staten
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Rijnstate HospitalVoltooid
Klinische onderzoeken op Apatinib
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Lei LiVoltooidChemotherapie | Recidiverend cervicaal carcinoom | Apatinib | Gerichte therapie | Aanhoudend gevorderd cervicaal carcinoom | Vasculaire endotheliale groeifactor 2-remmerChina
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Peking University Cancer Hospital & InstituteWerving
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Huazhong University of Science and TechnologyOnbekend
-
The First Affiliated Hospital of Zhengzhou UniversityWervingSlokdarmkanker door AJCC V8 StageChina
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Peking UniversityJiangsu HengRui Medicine Co., Ltd.Werving
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The First Affiliated Hospital of Zhengzhou UniversityWerving
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Sun Yat-sen UniversityNog niet aan het wervenNSCLC | Niet-kleincellige longkankerChina
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Beijing HospitalChinese Society of Clinical OncologyWerving
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Shanghai Chest HospitalOnbekendHerhaling | Metastase | Slokdarm plaveiselcelcarcinoom | ApatinibChina
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Peking Union Medical College HospitalVoltooid