<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03229096</url>
  </required_header>
  <id_info>
    <org_study_id>ZSGC-002</org_study_id>
    <nct_id>NCT03229096</nct_id>
  </id_info>
  <brief_title>Apatinib Plus XELOX as Neoadjuvant Therapy in Locally Advanced Gastric Cancer</brief_title>
  <official_title>Apatinib Plus XELOX Regime as Neoadjuvant Therapy in Locally Advanced Gastric Cancer Patients With Lymph Node Metastasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Apatinib plus XELOX regime as Neoadjuvant Therapy in Locally Advanced Gastric Cancer&#xD;
      PatientsWith lymph node metastasis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Single-center, Open-label, Single-arm,Non-randomized exploratory clinical trial&#xD;
      evaluating the efficacy and safety of Apatinib plus XELOX regime as Neoadjuvant Therapy in&#xD;
      Locally Advanced Gastric Cancer Patients With lymph node metastasis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>3 months</time_frame>
    <description>Both CR and PR according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>30 days</time_frame>
    <description>The safety of the the perioperative treatment, percentage of grade 3 or 4 adverse events as safety profile of perioperative treatments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pathological response rate (pRR)</measure>
    <time_frame>30 days</time_frame>
    <description>Briefly, pathCR (Pathological complete rate) was defined as an absence of carcinoma cells in the primary site, and pathologic partial response (pathPR) was defined as less than 10% residual carcinoma cells in the specimen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-year disease free survival rate</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-year overall survival rate</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Chemotherapy Effect</condition>
  <condition>Chemotherapeutic Toxicity</condition>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Apatinib plus XELOX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be given the perioperative chemotherapy of Apatinib plus XELOX once recruited</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib plus XELOX</intervention_name>
    <description>three weeks is one cycle, 4 cycles followed by radical gastrectomy. Apatinib: 250 mg, p.o., qd, every 3 weeks for the first two cycles. if no level 3 or severer AEs happened, change apatinib to 500mg, p.o.,qd, otherwise keep 250mg in the third cycle. no apatinib in the fourth cycle.&#xD;
Capecitabine: 1000mg/m2, p.o., bid, D1-14, every 3 weeks (treatment for 2 weeks and rest 1 week).&#xD;
Oxaliplatin: 130mg/m2, i.v. over 2h, D1, every 3 weeks.</description>
    <arm_group_label>Apatinib plus XELOX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients, age ≥18 years.&#xD;
&#xD;
          2. Karnofsky score 70%.&#xD;
&#xD;
          3. Histologically confirmed adenocarcinoma of gastric cancer with Lauren classification&#xD;
             Clinically diagnosed stage T2-T4aN+M0 according to CT/MRI scan.&#xD;
&#xD;
          4. At least one measurable and evaluable disease based on response evaluation criteria in&#xD;
             solid tumors (RECIST v1.1), that is one or more perigastric lymph note were greater&#xD;
             than or equal to 1.5cm in diameter.&#xD;
&#xD;
          5. Laparoscopic exploration confirms no peritoneal metastasis and negative peritoneal&#xD;
             lavage.&#xD;
&#xD;
          6. Physical condition and adequate organ function to ensure the success of abdominal&#xD;
             surgery.&#xD;
&#xD;
          7. Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 ×&#xD;
             109/L and Hemoglobin ≥8g/dL. Adequate liver function: Total bilirubin ≤ 1.5 × upper&#xD;
             limit of normal (ULN); AST (SGOT) and ALT (SGPT) &lt; 2.5 × ULN. ALP ≤ 2.5 × upper limit&#xD;
             of normal (ULN); ALB ≥30g/L.Adequate renal function: Serum creatinine ≤ 1 x ULN, and&#xD;
             serum albumin≥30g/L.&#xD;
&#xD;
          8. Life expectancy of more than 5 years without serious concomitant diseases.&#xD;
&#xD;
          9. Written (signed) informed consent.&#xD;
&#xD;
         10. Able to comply with study and follow-up procedures.&#xD;
&#xD;
         11. Consent to provide tissue sample.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or lactating women.&#xD;
&#xD;
          2. pregnancy tests before entering the group (in serum) of the childbearing age women&#xD;
             were positive, or no pregnancy tests.&#xD;
&#xD;
          3. patients with distant metastases or local unresectable factors.&#xD;
&#xD;
          4. tumor stage considered as cT1 by imaging or ultrasound gastroscopy.&#xD;
&#xD;
          5. Patients who received prior anti-tumor therapy including cytotoxic chemotherapy,&#xD;
             radiotherapy, hormonal therapy and immunotherapy.&#xD;
&#xD;
          6. History of other malignancies within the last 5 years except cured basal cell&#xD;
             carcinoma of skin and carcinoma in situ of uterine cervix.&#xD;
&#xD;
          7. History of significant neurological or mental disorder, including seizures or&#xD;
             dementia, which may interfere compliance and sign of consent inform.&#xD;
&#xD;
          8. Unstable, persistent cardiac disease despite medicinal treatment; myocardial&#xD;
             infarction within 12 months before the start of the trial.&#xD;
&#xD;
          9. Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg&#xD;
             and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management.&#xD;
&#xD;
         10. Ileus, chronic inflammatory intestinal disease or extensive resection of the small&#xD;
             intestine and other disorders which limit drug absorption.&#xD;
&#xD;
         11. Patients who experienced GI bleeding within two weeks, or with high risk of bleeding.&#xD;
&#xD;
         12. Patients with symptomatic peripheral neuropathy NCI CTC version&gt; 1.0 grade, except&#xD;
             only the deficiency of Deep tendon reflex.&#xD;
&#xD;
         13. Organ transplant patient need immunosuppression treatment.&#xD;
&#xD;
         14. Active or uncontrolled severe infection or other severe and /or uncontrolled diseases&#xD;
&#xD;
         15. Patients with moderate or severe chronic kidney disease estimated glomerular&#xD;
             filtration rate≤50 ml/min or serum creatinine ≥the upper limit of normal(ULN),&#xD;
&#xD;
         16. deficiency of dihydropyrimidine dehydrogenase (DPD)&#xD;
&#xD;
         17. Allergy to the drugs in this protocol&#xD;
&#xD;
         18. Less than 4 weeks from the last clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Zhaoqing Tang, MD</last_name>
    <phone>86-21-64041990</phone>
    <phone_ext>2910</phone_ext>
    <email>tang.zhaoqing@zs-hospital.sh.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>ZhongShan hospital FuDan university</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi-Hong Sun, MD</last_name>
      <phone>86-13701735406</phone>
      <email>sun.yihong@zs-hospital.sh.cn</email>
    </contact>
    <investigator>
      <last_name>Yi-Hong Sun, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Sasako M, Sano T, Yamamoto S, Kurokawa Y, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K; Japan Clinical Oncology Group. D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer. N Engl J Med. 2008 Jul 31;359(5):453-62. doi: 10.1056/NEJMoa0707035.</citation>
    <PMID>18669424</PMID>
  </reference>
  <reference>
    <citation>Songun I, Putter H, Kranenbarg EM, Sasako M, van de Velde CJ. Surgical treatment of gastric cancer: 15-year follow-up results of the randomised nationwide Dutch D1D2 trial. Lancet Oncol. 2010 May;11(5):439-49. doi: 10.1016/S1470-2045(10)70070-X. Epub 2010 Apr 19.</citation>
    <PMID>20409751</PMID>
  </reference>
  <reference>
    <citation>Fujitani K, Yang HK, Mizusawa J, Kim YW, Terashima M, Han SU, Iwasaki Y, Hyung WJ, Takagane A, Park DJ, Yoshikawa T, Hahn S, Nakamura K, Park CH, Kurokawa Y, Bang YJ, Park BJ, Sasako M, Tsujinaka T; REGATTA study investigators. Gastrectomy plus chemotherapy versus chemotherapy alone for advanced gastric cancer with a single non-curable factor (REGATTA): a phase 3, randomised controlled trial. Lancet Oncol. 2016 Mar;17(3):309-318. doi: 10.1016/S1470-2045(15)00553-7. Epub 2016 Jan 26.</citation>
    <PMID>26822397</PMID>
  </reference>
  <reference>
    <citation>Sano T, Coit DG, Kim HH, Roviello F, Kassab P, Wittekind C, Yamamoto Y, Ohashi Y. Proposal of a new stage grouping of gastric cancer for TNM classification: International Gastric Cancer Association staging project. Gastric Cancer. 2017 Mar;20(2):217-225. doi: 10.1007/s10120-016-0601-9. Epub 2016 Feb 20.</citation>
    <PMID>26897166</PMID>
  </reference>
  <reference>
    <citation>Yoshikawa T, Sasako M, Yamamoto S, Sano T, Imamura H, Fujitani K, Oshita H, Ito S, Kawashima Y, Fukushima N. Phase II study of neoadjuvant chemotherapy and extended surgery for locally advanced gastric cancer. Br J Surg. 2009 Sep;96(9):1015-22. doi: 10.1002/bjs.6665.</citation>
    <PMID>19644974</PMID>
  </reference>
  <reference>
    <citation>Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.</citation>
    <PMID>16822992</PMID>
  </reference>
  <reference>
    <citation>Iwasaki Y, Sasako M, Yamamoto S, Nakamura K, Sano T, Katai H, Tsujinaka T, Nashimoto A, Fukushima N, Tsuburaya A; Gastric Cancer Surgical Study Group of Japan Clinical Oncology Group. Phase II study of preoperative chemotherapy with S-1 and cisplatin followed by gastrectomy for clinically resectable type 4 and large type 3 gastric cancers (JCOG0210). J Surg Oncol. 2013 Jun;107(7):741-5. doi: 10.1002/jso.23301. Epub 2013 Feb 11.</citation>
    <PMID>23400787</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22154885</PMID>
  </reference>
  <reference>
    <citation>Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M. S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol. 2008 Mar;9(3):215-21. doi: 10.1016/S1470-2045(08)70035-4. Epub 2008 Feb 20.</citation>
    <PMID>18282805</PMID>
  </reference>
  <reference>
    <citation>Boku N, Yamamoto S, Fukuda H, Shirao K, Doi T, Sawaki A, Koizumi W, Saito H, Yamaguchi K, Takiuchi H, Nasu J, Ohtsu A; Gastrointestinal Oncology Study Group of the Japan Clinical Oncology Group. Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomised phase 3 study. Lancet Oncol. 2009 Nov;10(11):1063-9. doi: 10.1016/S1470-2045(09)70259-1. Epub 2009 Oct 7.</citation>
    <PMID>19818685</PMID>
  </reference>
  <reference>
    <citation>Tsuburaya A, Mizusawa J, Tanaka Y, Fukushima N, Nashimoto A, Sasako M; Stomach Cancer Study Group of the Japan Clinical Oncology Group. Neoadjuvant chemotherapy with S-1 and cisplatin followed by D2 gastrectomy with para-aortic lymph node dissection for gastric cancer with extensive lymph node metastasis. Br J Surg. 2014 May;101(6):653-60. doi: 10.1002/bjs.9484. Epub 2014 Mar 25.</citation>
    <PMID>24668391</PMID>
  </reference>
  <reference>
    <citation>Ito S, Sano T, Mizusawa J, Takahari D, Katayama H, Katai H, Kawashima Y, Kinoshita T, Terashima M, Nashimoto A, Nakamori M, Onaya H, Sasako M. A phase II study of preoperative chemotherapy with docetaxel, cisplatin, and S-1 followed by gastrectomy with D2 plus para-aortic lymph node dissection for gastric cancer with extensive lymph node metastasis: JCOG1002. Gastric Cancer. 2017 Mar;20(2):322-331. doi: 10.1007/s10120-016-0619-z. Epub 2016 Jun 14.</citation>
    <PMID>27299887</PMID>
  </reference>
  <reference>
    <citation>Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19. Erratum In: Lancet. 2010 Oct 16;376(9749):1302.</citation>
    <PMID>20728210</PMID>
  </reference>
  <reference>
    <citation>Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17.</citation>
    <PMID>25240821</PMID>
  </reference>
  <reference>
    <citation>Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.</citation>
    <PMID>26884585</PMID>
  </reference>
  <reference>
    <citation>Okines AF, Langley RE, Thompson LC, Stenning SP, Stevenson L, Falk S, Seymour M, Coxon F, Middleton GW, Smith D, Evans L, Slater S, Waters J, Ford D, Hall M, Iveson TJ, Petty RD, Plummer C, Allum WH, Blazeby JM, Griffin M, Cunningham D. Bevacizumab with peri-operative epirubicin, cisplatin and capecitabine (ECX) in localised gastro-oesophageal adenocarcinoma: a safety report. Ann Oncol. 2013 Mar;24(3):702-9. doi: 10.1093/annonc/mds533. Epub 2012 Oct 28.</citation>
    <PMID>23108952</PMID>
  </reference>
  <reference>
    <citation>Kataoka K, Tokunaga M, Mizusawa J, Machida N, Katayama H, Shitara K, Tomita T, Nakamura K, Boku N, Sano T, Terashima M, Sasako M; Stomach Cancer Study Group/Japan Clinical Oncology Group. A randomized Phase II trial of systemic chemotherapy with and without trastuzumab followed by surgery in HER2-positive advanced gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis: Japan Clinical Oncology Group study JCOG1301 (Trigger Study). Jpn J Clin Oncol. 2015 Nov;45(11):1082-6. doi: 10.1093/jjco/hyv134. Epub 2015 Sep 9.</citation>
    <PMID>26355164</PMID>
  </reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>July 22, 2017</study_first_submitted>
  <study_first_submitted_qc>July 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>June 26, 2019</last_update_submitted>
  <last_update_submitted_qc>June 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gastric cancer</keyword>
  <keyword>neoadjuvant chemotherapy</keyword>
  <keyword>apatinib</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apatinib</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>April 11, 2022</submitted>
    <returned>January 6, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03229096
org study id: ZSGC-002
nct id: NCT03229096
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Apatinib plus XELOX regime as Neoadjuvant Therapy in Locally Advanced Gastric Cancer
      PatientsWith lymph node metastasis
This is a Single-center, Open-label, Single-arm,Non-randomized exploratory clinical trial
      evaluating the efficacy and safety of Apatinib plus XELOX regime as Neoadjuvant Therapy in
      Locally Advanced Gastric Cancer Patients With lymph node metastasis
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate (ORR)
time frame: 3 months
description: Both CR and PR according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: 30 days
description: The safety of the the perioperative treatment, percentage of grade 3 or 4 adverse events as safety profile of perioperative treatments
measure: Pathological response rate (pRR)
time frame: 30 days
description: Briefly, pathCR (Pathological complete rate) was defined as an absence of carcinoma cells in the primary site, and pathologic partial response (pathPR) was defined as less than 10% residual carcinoma cells in the specimen.
measure: 3-year disease free survival rate
time frame: 3 years
measure: 3-year overall survival rate
time frame: 3 years
arm group label: Apatinib plus XELOX
arm group type: Experimental
description: Patients will be given the perioperative chemotherapy of Apatinib plus XELOX once recruited
intervention type: Drug
intervention name: Apatinib plus XELOX
description: three weeks is one cycle, 4 cycles followed by radical gastrectomy. Apatinib: 250 mg, p.o., qd, every 3 weeks for the first two cycles. if no level 3 or severer AEs happened, change apatinib to 500mg, p.o.,qd, otherwise keep 250mg in the third cycle. no apatinib in the fourth cycle.
Capecitabine: 1000mg/m2, p.o., bid, D1-14, every 3 weeks (treatment for 2 weeks and rest 1 week).
Oxaliplatin: 130mg/m2, i.v. over 2h, D1, every 3 weeks.
arm group label: Apatinib plus XELOX
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Zhaoqing Tang, MD
phone: 86-21-64041990
phone ext: 2910
email: tang.zhaoqing@zs-hospital.sh.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
citation: Sasako M, Sano T, Yamamoto S, Kurokawa Y, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K; Japan Clinical Oncology Group. D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer. N Engl J Med. 2008 Jul 31;359(5):453-62. doi: 10.1056/NEJMoa0707035.
PMID: 18669424
citation: Songun I, Putter H, Kranenbarg EM, Sasako M, van de Velde CJ. Surgical treatment of gastric cancer: 15-year follow-up results of the randomised nationwide Dutch D1D2 trial. Lancet Oncol. 2010 May;11(5):439-49. doi: 10.1016/S1470-2045(10)70070-X. Epub 2010 Apr 19.
PMID: 20409751
citation: Fujitani K, Yang HK, Mizusawa J, Kim YW, Terashima M, Han SU, Iwasaki Y, Hyung WJ, Takagane A, Park DJ, Yoshikawa T, Hahn S, Nakamura K, Park CH, Kurokawa Y, Bang YJ, Park BJ, Sasako M, Tsujinaka T; REGATTA study investigators. Gastrectomy plus chemotherapy versus chemotherapy alone for advanced gastric cancer with a single non-curable factor (REGATTA): a phase 3, randomised controlled trial. Lancet Oncol. 2016 Mar;17(3):309-318. doi: 10.1016/S1470-2045(15)00553-7. Epub 2016 Jan 26.
PMID: 26822397
citation: Sano T, Coit DG, Kim HH, Roviello F, Kassab P, Wittekind C, Yamamoto Y, Ohashi Y. Proposal of a new stage grouping of gastric cancer for TNM classification: International Gastric Cancer Association staging project. Gastric Cancer. 2017 Mar;20(2):217-225. doi: 10.1007/s10120-016-0601-9. Epub 2016 Feb 20.
PMID: 26897166
citation: Yoshikawa T, Sasako M, Yamamoto S, Sano T, Imamura H, Fujitani K, Oshita H, Ito S, Kawashima Y, Fukushima N. Phase II study of neoadjuvant chemotherapy and extended surgery for locally advanced gastric cancer. Br J Surg. 2009 Sep;96(9):1015-22. doi: 10.1002/bjs.6665.
PMID: 19644974
citation: Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.
PMID: 16822992
citation: Iwasaki Y, Sasako M, Yamamoto S, Nakamura K, Sano T, Katai H, Tsujinaka T, Nashimoto A, Fukushima N, Tsuburaya A; Gastric Cancer Surgical Study Group of Japan Clinical Oncology Group. Phase II study of preoperative chemotherapy with S-1 and cisplatin followed by gastrectomy for clinically resectable type 4 and large type 3 gastric cancers (JCOG0210). J Surg Oncol. 2013 Jun;107(7):741-5. doi: 10.1002/jso.23301. Epub 2013 Feb 11.
PMID: 23400787
citation: 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.
PMID: 22154885
citation: Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M. S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol. 2008 Mar;9(3):215-21. doi: 10.1016/S1470-2045(08)70035-4. Epub 2008 Feb 20.
PMID: 18282805
citation: Boku N, Yamamoto S, Fukuda H, Shirao K, Doi T, Sawaki A, Koizumi W, Saito H, Yamaguchi K, Takiuchi H, Nasu J, Ohtsu A; Gastrointestinal Oncology Study Group of the Japan Clinical Oncology Group. Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomised phase 3 study. Lancet Oncol. 2009 Nov;10(11):1063-9. doi: 10.1016/S1470-2045(09)70259-1. Epub 2009 Oct 7.
PMID: 19818685
citation: Tsuburaya A, Mizusawa J, Tanaka Y, Fukushima N, Nashimoto A, Sasako M; Stomach Cancer Study Group of the Japan Clinical Oncology Group. Neoadjuvant chemotherapy with S-1 and cisplatin followed by D2 gastrectomy with para-aortic lymph node dissection for gastric cancer with extensive lymph node metastasis. Br J Surg. 2014 May;101(6):653-60. doi: 10.1002/bjs.9484. Epub 2014 Mar 25.
PMID: 24668391
citation: Ito S, Sano T, Mizusawa J, Takahari D, Katayama H, Katai H, Kawashima Y, Kinoshita T, Terashima M, Nashimoto A, Nakamori M, Onaya H, Sasako M. A phase II study of preoperative chemotherapy with docetaxel, cisplatin, and S-1 followed by gastrectomy with D2 plus para-aortic lymph node dissection for gastric cancer with extensive lymph node metastasis: JCOG1002. Gastric Cancer. 2017 Mar;20(2):322-331. doi: 10.1007/s10120-016-0619-z. Epub 2016 Jun 14.
PMID: 27299887
citation: Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19. Erratum In: Lancet. 2010 Oct 16;376(9749):1302.
PMID: 20728210
citation: Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17.
PMID: 25240821
citation: Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.
PMID: 26884585
citation: Okines AF, Langley RE, Thompson LC, Stenning SP, Stevenson L, Falk S, Seymour M, Coxon F, Middleton GW, Smith D, Evans L, Slater S, Waters J, Ford D, Hall M, Iveson TJ, Petty RD, Plummer C, Allum WH, Blazeby JM, Griffin M, Cunningham D. Bevacizumab with peri-operative epirubicin, cisplatin and capecitabine (ECX) in localised gastro-oesophageal adenocarcinoma: a safety report. Ann Oncol. 2013 Mar;24(3):702-9. doi: 10.1093/annonc/mds533. Epub 2012 Oct 28.
PMID: 23108952
citation: Kataoka K, Tokunaga M, Mizusawa J, Machida N, Katayama H, Shitara K, Tomita T, Nakamura K, Boku N, Sano T, Terashima M, Sasako M; Stomach Cancer Study Group/Japan Clinical Oncology Group. A randomized Phase II trial of systemic chemotherapy with and without trastuzumab followed by surgery in HER2-positive advanced gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis: Japan Clinical Oncology Group study JCOG1301 (Trigger Study). Jpn J Clin Oncol. 2015 Nov;45(11):1082-6. doi: 10.1093/jjco/hyv134. Epub 2015 Sep 9.
PMID: 26355164
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Apatinib
submitted: April 11, 2022
returned: January 6, 2023