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Apatinib Combined With SOX Neoadjuvant Chemotherapy for Locally Advanced Gastric Cance

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ClinicalTrials.gov Identifier: NCT03192735
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Chang-Ming Huang, Prof., Fujian Medical University

Brief Summary:
We star a multicentre, one-armed, clinical pilot trial intends to investigate the safety and effectiveness of Apatinib Combined With Oxaliplatin, Gimeracil and Oteracil Porassium Capsules Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer(cT2-4/N+M0)

Condition or disease Intervention/treatment Phase
Safety and Effectiveness of Apatinib Combined With SOX Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer Drug: ApatinibMesylateTablets Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Apatinib Combined With Oxaliplatin and Gimeracil and Oteracil Porassium Capsules Neoadjuvant Chemotherapy for Locally Advanced Gastric Cance: A Multicentre, One-armed, Clinical Pilot Trial
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: Apatinib Combined With SOX
In this group,subject will be given ApatinibMesylateTablets 500mg one time a day, from day1-day 21,per os; Oxaliplatin for Injection 130mg/m2 one time a day,ivgtt,in day1; Gimeracil and Oteracil Porassium Capsules twice times a day,from day1-day 14,per os,and the dosage according body surface area:<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; >1.5m2, 60mg every time.A course of treatment need 21days. Every subject need 2-5 courses accrding to tumor assessment by clinician. The last course stop ApatinibMesylateTablets.
Drug: ApatinibMesylateTablets
Subject will be given ApatinibMesylateTablets 500mg/per day, from day1-day 21,per os; Oxaliplatin for Injection 130mg/m2 /per day,ivgtt,in day1; Gimeracil and Oteracil Porassium Capsules twice times a day,from day1-day 14,per os,and the dosage according body surface area:<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; >1.5m2, 60mg every time.A course of treatment need 21days. Every subject need 2-5 courses accrding to tumor assessment by clinician. The last course stop ApatinibMesylateTablets.
Other Names:
  • Oxaliplatin for Injection
  • Gimeracil and Oteracil Porassium Capsules




Primary Outcome Measures :
  1. Radical surgical resection rate [ Time Frame: 30 days ]
    Radical surgical resection rate is defined as the rate of R0 resection


Secondary Outcome Measures :
  1. Pathological response rate [ Time Frame: 30 days ]
    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.

  2. overall response rate [ Time Frame: 30 days ]
    according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1

  3. 5-year overall survival rate [ Time Frame: 60 months ]
  4. 5-year disease free survival rate [ Time Frame: 60months ]
  5. overall postoperative morbidity rates [ Time Frame: 30 days ]
    Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.

  6. Duration of postoperative hospital stay [ Time Frame: 30 days ]
    Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.

  7. 30 days mortality rates [ Time Frame: 30 days ]
    Defined as the event observed within 30 days after surgery.

  8. adverse event [ Time Frame: 60 months ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age from 18 to 75 years
  2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  3. cT2-4N+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  4. No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
  5. Performance status of 0 or 2 on Eastern Cooperative Oncology Group scale (ECOG)
  6. Without previous surgical, chemotherapy,radiotherapy, immunotherapy, or targeted therapy for gastric cancer.
  7. Estimate life is equal or greater than 3 months
  8. No serious heart, lung, liver dysfunction;no Jaundice and obstruction of the digestive tract; no acute infection
  9. The main organ function is normal,and meet the following criteria:

    • blood routine examination( No blood transfusion within 14 days)

      1. HB≥100g/L,
      2. WBC≥3.5×109/L
      3. ANC≥1.5×109/L,
      4. PLT≥100×109/L;
    • blood biochemical examination

      1. BIL <1.5 Upper Limit Of Normal(ULN),
      2. ALT and AST<2.5ULN,GPT≤1.5×ULT;
      3. Cr≤1ULN,creatinine clearance>60ml/min(Cockcroft-Gault formula)
  10. Written informed consent

Exclusion Criteria:

  1. Pregnant and lactating women
  2. Suffering from severe mental disorder
  3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
  4. History of previous chemotherapy or radiotherapy therapy
  5. History of other malignant disease within the past 5 years
  6. History of previous neoadjuvant chemotherapy or radiotherapy
  7. History of unstable angina or myocardial infarction within the past 6 months
  8. History of cerebrovascular accident within the past 6 months
  9. History of continuous systematic administration of corticosteroids within 1 month
  10. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  11. Patients with a clear tendency of gastrointestinal bleeding,such as: active ulceration,fecal occult blood test(++),The history of hematemesis and melena within 2 months,coagulation disorders(INR>1.5、APTT>1.5 ULN).
  12. Positive urinary protein(uric albumen check(++),or Twenty-four hours urinary protein content>1.0g)
  13. There are several factors that affect oral medicine,such as unable to swallow, uncontrollable nausea and vomitin, or chronic diarrhea and intestinal obstruction
  14. Drug allergy to experimental medicine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192735


Locations
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China, Fujian
Fujian Medical University Union Hospital Recruiting
Fuzhou, Fujian, China, 350000
Contact: Changming Huang, Professor    8613805069676    hcmlr2002@163.com   
Contact: Ruhong Tu, M.D    8615980278081    794561137@qq.com   
Sponsors and Collaborators
Chang-Ming Huang, Prof.

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Responsible Party: Chang-Ming Huang, Prof., Principal Investigator, Fujian Medical University
ClinicalTrials.gov Identifier: NCT03192735     History of Changes
Other Study ID Numbers: 2017YF004-03
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Oxaliplatin
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action