The Study of Conversion Surgery for Apatinib in Combination With SOX for Patients With Unresectable Gastric Cancer
NCT ID: NCT03007446
Last Updated: 2017-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2016-11-30
2018-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Apatinib plus Oxaliplatin/S-1
1. Apatinib :
A starting dose of apatinib was administered 500 mg daily on days 1 through 21 of each 3-week cycle.
2. Oxaliplatin:130 mg/m2，d1，ivgtt，in a 21 day cycle.
3. S-1:40mg，bid，d1-14，po，in a 21 day cycle.
Apatinib
Apatinib :A starting dose of apatinib was administered 500 mg daily
Oxaliplatin
Oxaliplatin:130 mg/m2，d1，ivgtt，in a 21 day cycle
S-1
S-1:40mg，bid，d1-14，po，in a 21 day cycle.
Interventions
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Apatinib
Apatinib :A starting dose of apatinib was administered 500 mg daily
Oxaliplatin
Oxaliplatin:130 mg/m2，d1，ivgtt，in a 21 day cycle
S-1
S-1:40mg，bid，d1-14，po，in a 21 day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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) ;
3. Definitely diagnosed as unresectable gastric cancer via exploratory laparoscopy or laparotomy;
4. ECOG performance status 0-2;
5. Age 18-70 years old, Life expectancy estimated than 3 months;
6. For results of blood routine test and biochemical tests:
1. Hgb ≥ 80g/L,
2. WBC ≥ 4000/mm3,
3. ANC ≥ 1.5×109/L,
4. platelets ≥ 80×109/L
5. ALT and AST ≤ 2.5 x upper normal limit (UNL), and ≤ 5 x UNL（Hematogenous metastases）,
6. Serum Total bilirubin ≤ 1.5 X UNL,
7. Serum Creatine ≤ 1.5 x UNL ；
7. Good cardiac function before the recruitment, no seizure of myocardial infarction in past half years, and controllable hypertension and other coronary heart disease;
8. Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver);
9. informed consent.
Exclusion Criteria
2. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
3. 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;
4. 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;
5. Abnormal Coagulation (INR\>1.5, APTT\>1.5 UNL), with tendency of bleed;
6. Pregnant or lactating women;
7. Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
8. Treatment with prior radiotherapy, chemotherapy, Targeted therapy or immunotherapy;
9. Other conditions regimented at investigators' discretion.
18 Years
70 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Lin Chen
Director of the General Surgery Department, Chinese PLA General Hospital
Principal Investigators
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Lin Chen
Role: PRINCIPAL_INVESTIGATOR
the Chinese PLA General Hospital
Locations
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the chinese PLA General Hospital
Beijing, , China
Countries
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Central Contacts
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Hongqing Xi, Master
Role: CONTACT
Facility Contacts
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Lin Chen, Master
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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Ahead-BG301
Identifier Type: -
Identifier Source: org_study_id