- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03007446
The Study of Conversion Surgery for Apatinib in Combination With SOX for Patients With Unresectable Gastric Cancer
The Exploratory Study of Conversion Surgery for Apatinib in Combination With Oxaliplatin/S-1(SOX) for Patients With Unresectable Gastric Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Gastric cancer is the second most common cause of cancer-related deaths worldwide, and surgical resection during the early stage has improved treatment outcomes.However, many patients are diagnosed with unresectable advanced or metastatic stage disease losing the radical surgery opportunity. Systemic chemotherapy is the leading treatment that prolongs survival times for such patients.
Approximate 20 patients with unresectable gastric cancer will be enrolled in this study,the investigators will evaluate the efficacy and security of Apatinib + SOX(oxaliplatin+S-1) for unresectable gastric cancer.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Beijing, Kina, 100853
- Rekruttering
- The Chinese PLA General Hospital
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Kontakt:
- Lin Chen, Master
- Telefonnummer: 13801290395
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Histologically proved gastric adenocarcinoma;
- At least a unresectable factor before operation via CT, MRI, or PET-CT: difficult resection of locally advanced gastric cancer(T4b); hepatic metastasis (H1; at most five lesions, total diameter ≤8 cm); Peritoneal metastasis(CY1, P1) ;
- Definitely diagnosed as unresectable gastric cancer via exploratory laparoscopy or laparotomy;
- ECOG performance status 0-2;
- Age 18-70 years old, Life expectancy estimated than 3 months;
For results of blood routine test and biochemical tests:
- Hgb ≥ 80g/L,
- WBC ≥ 4000/mm3,
- ANC ≥ 1.5×109/L,
- platelets ≥ 80×109/L
- ALT and AST ≤ 2.5 x upper normal limit (UNL), and ≤ 5 x UNL(Hematogenous metastases),
- Serum Total bilirubin ≤ 1.5 X UNL,
- Serum Creatine ≤ 1.5 x UNL ;
- Good cardiac function before the recruitment, no seizure of myocardial infarction in past half years, and controllable hypertension and other coronary heart disease;
- Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver);
- informed consent.
Exclusion Criteria:
- Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than Class I; I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class I cardiac dysfunction; Patients with positive urinary protein;
- Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;
- Contraindications include allergy to apatinib and/or its accessories, active bleeding, intestinal perforation, intestinal obstruction, within 30 days after surgery, drugs with poor-controlled hypertension, Class Ⅲ-Ⅳ cardiac dysfunction (NYHA standard), severe hepatic and renal dysfunction(level 4)if apatinib use is considered;
- Abnormal Coagulation (INR>1.5, APTT>1.5 UNL), with tendency of bleed;
- Pregnant or lactating women;
- Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
- Treatment with prior radiotherapy, chemotherapy, Targeted therapy or immunotherapy;
- Other conditions regimented at investigators' discretion.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Apatinib plus Oxaliplatin/S-1
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Apatinib :A starting dose of apatinib was administered 500 mg daily
Andre navne:
Oxaliplatin:130 mg/m2,d1,ivgtt,in a 21 day cycle
S-1:40mg,bid,d1-14,po,in a 21 day cycle.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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reaction rate
Tidsramme: 4 months
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4 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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uønskede hændelser
Tidsramme: 6 måneder
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6 måneder
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Samlet overlevelse
Tidsramme: 3 år
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3 år
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Objective Response Rate
Tidsramme: an expected average of 6 weeks
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an expected average of 6 weeks
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Disease-free survival
Tidsramme: an expected average of 6 weeks
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an expected average of 6 weeks
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Progression-Free Survival
Tidsramme: an expected average of 6 weeks
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an expected average of 6 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Lin Chen, The Chinese PLA General Hospital
Publikationer og nyttige links
Generelle publikationer
- Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, Dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero J; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014 Jan 4;383(9911):31-39. doi: 10.1016/S0140-6736(13)61719-5. Epub 2013 Oct 3.
- Kitayama J, Ishigami H, Yamaguchi H, Yamashita H, Emoto S, Kaisaki S, Watanabe T. Salvage gastrectomy after intravenous and intraperitoneal paclitaxel (PTX) administration with oral S-1 for peritoneal dissemination of advanced gastric cancer with malignant ascites. Ann Surg Oncol. 2014 Feb;21(2):539-46. doi: 10.1245/s10434-013-3208-y. Epub 2013 Aug 22.
- Li J, Qin S, Xu J, Guo W, Xiong J, Bai Y, Sun G, Yang Y, Wang L, Xu N, Cheng Y, Wang Z, Zheng L, Tao M, Zhu X, Ji D, Liu X, Yu H. Apatinib for chemotherapy-refractory advanced metastatic gastric cancer: results from a randomized, placebo-controlled, parallel-arm, phase II trial. J Clin Oncol. 2013 Sep 10;31(26):3219-25. doi: 10.1200/JCO.2013.48.8585. Epub 2013 Aug 5.
- Fukuchi M, Ishiguro T, Ogata K, Suzuki O, Kumagai Y, Ishibashi K, Ishida H, Kuwano H, Mochiki E. Prognostic Role of Conversion Surgery for Unresectable Gastric Cancer. Ann Surg Oncol. 2015 Oct;22(11):3618-24. doi: 10.1245/s10434-015-4422-6. Epub 2015 Feb 7.
- Kanda T, Yajima K, Kosugi S, Ishikawa T, Ajioka Y, Hatakeyama K. Gastrectomy as a secondary surgery for stage IV gastric cancer patients who underwent S-1-based chemotherapy: a multi-institute retrospective study. Gastric Cancer. 2012 Jul;15(3):235-44. doi: 10.1007/s10120-011-0100-y. Epub 2011 Oct 28.
- Inoue K, Nakane Y, Kogire M, Fujitani K, Kimura Y, Imamura H, Tamura S, Okano S, Kwon AH, Kurokawa Y, Shimokawa T, Takiuchi H, Tsujinaka T, Furukawa H. Phase II trial of preoperative S-1 plus cisplatin followed by surgery for initially unresectable locally advanced gastric cancer. Eur J Surg Oncol. 2012 Feb;38(2):143-9. doi: 10.1016/j.ejso.2011.11.009. Epub 2011 Dec 9.
- Ohtsu A, Shah MA, Van Cutsem E, Rha SY, Sawaki A, Park SR, Lim HY, Yamada Y, Wu J, Langer B, Starnawski M, Kang YK. Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol. 2011 Oct 20;29(30):3968-76. doi: 10.1200/JCO.2011.36.2236. Epub 2011 Aug 15.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Mavesygdomme
- Neoplasmer i maven
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Proteinkinasehæmmere
- Oxaliplatin
- Apatinib
Andre undersøgelses-id-numre
- Ahead-BG301
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Mavekræft
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Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AfsluttetRoux-en-Y Gastric Bypass | Bariatrisk kirurgi | Vertikal ærmegatrektomi | Mavebånd | Bypass, GastricForenede Stater
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Medtronic - MITGAfsluttet
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DuomedAktiv, ikke rekrutterendeFedme | Gastrectomi | Roux-en-Y Gastric Bypass | Mini Gastric BypassBelgien
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Olympus Corporation of the AmericasUnity Health TorontoAfsluttet
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North Dakota State UniversityNational Institutes of Health (NIH)AfsluttetRoux en Y Gastric Bypass OperationForenede Stater
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Jessa HospitalIkke rekrutterer endnu
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Wageningen UniversityRijnstate HospitalUkendtRoux-en-Y Gastric BypassHolland
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaAfsluttetRoux en Y Gastric BypassForenede Stater
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Rijnstate HospitalAfsluttetRoux-en-Y Gastric Bypass | Mavetømning | Bariatrisk kirurgiHolland
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Rijnstate HospitalAfsluttet
Kliniske forsøg med Apatinib
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Song PengIkke rekrutterer endnuHepatocellulært karcinom Ikke-operabeltKina
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First Affiliated Hospital of Chongqing Medical...Ikke rekrutterer endnuImmunmodulering | Hepatocellulære karcinomer | Resistens mod immunterapi | MedicintilpassningKina
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Guangzhou Virotech Pharmaceutical Co., Ltd.Rekruttering
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Fujian Medical UniversityIkke rekrutterer endnu
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Elevar TherapeuticsAfsluttetAdenoid cystisk karcinomForenede Stater, Korea, Republikken