Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Apatinib as Maintenance Therapy After First Line Treatment in Locally Advanced or Metastatic Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537171
Recruitment Status : Unknown
Verified August 2015 by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences.
Recruitment status was:  Recruiting
First Posted : September 1, 2015
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Brief Summary:
The study is to evaluate the efficacy of Apatinib in patients with advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: apatinib Phase 3

Detailed Description:
The study is to investigate the efficacy of Apatinib as maintenance therapy after first fine treatment in patients with advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction through progression-free survival(PFS). Apatinib will be given to patients who have received first-line chemotherapy with an efficacy assessment of stable disease(SD), complete response(CR), or partial response(PR) after 4 cycles. Patients were randomly assigned to 750mg group or 500mg group continually until disease progression or intolerable toxicity or patients withdrawal of consent, and the sample size is 40 individuals.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Apatinib as Maintenance Therapy After First Line Treatment in Locally Advanced or Metastatic Gastric Cancer: A Randomized, Parallel, Controlled Study
Study Start Date : July 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Active Comparator: Apatinib 750mg group
Apatinib mesylate tablets(ATAN) is taken 750mg every day orally, half hour after breakfast with warm water. The drug is taken 4 weeks one cycle until disease progression or intolerable toxicity or death.The dose of the study drug may be modified following the occurence of a clinically significant adverse event(AE).
Drug: apatinib
Patients will be randomly assigned on a 1:1 basis to treatment with Apatinib 750mg group or Apatinib 500mg group.
Other Name: ATAN

Active Comparator: Apatinib 500mg group
Apatinib Mesylate Tablets(ATAN) is taken 500mg every day orally, half hour after breakfast with warm water. The drug is taken 4 weeks one cycle until disease progression or intolerable toxicity or death.Treatment will be discontinued if the subject is unable to tolerate a daily dose of 500mg.
Drug: apatinib
Patients will be randomly assigned on a 1:1 basis to treatment with Apatinib 750mg group or Apatinib 500mg group.
Other Name: ATAN




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 1 year ]
    PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.


Secondary Outcome Measures :
  1. disease control rate(DCR) [ Time Frame: 1year ]
    Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1)

  2. Objective tumor response rate(ORR) [ Time Frame: 1year ]
    ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.

  3. overall survival(OS) [ Time Frame: 3year ]
    OS is defined as the length of time from random assignment to death or to last contact.

  4. Quality of life score (QoL) [ Time Frame: 1year ]
    QoL is a questionnaire developed to assess the quality of life of cancer patients.

  5. Adverse Events(AEs) [ Time Frame: 1year ]
    AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age≥18 years;
  2. Pathologically diagnosed with advanced gastric adenocarcinoma (including gastroesophageal junction) with measurable metastases outside the stomach (≥10mm on spiral CT scan, and meet the criteria of Response Evaluation Criteria in Solid Tumors 1.1);
  3. Locally advanced, recurrent or metastatic gastric or gastro-oesophageal junction adenocarcinoma;
  4. Finished first-line chemotherapy (fluorouracil combined with oxaliplatin, cisplatin, paclitaxel or docetaxel) 3 weeks a cycle for 4 cycles, of which the last efficacy assessment is SD, PR or CR. No more than 28 days from the starting day of last cycle of chemotherapy;
  5. Eastern Cooperative Oncology Group(ECOG)performance status 0 or 1;
  6. Blood routine test and Biochemical tests:

    • Hemoglobin ≥ 80g / L;
    • Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L;
    • Platelet count≥ 90 × 109 / L;
    • Alanine aminotransferase (ALT)and Aspartate aminotransferase (AST) <2.5× upper limit of normal (ULN); liver metastases, if any, the ALT and AST<5 × ULN;
    • Serum total bilirubin≤1.5 × ULN;
    • Serum creatinine≤1.5 × ULN;
    • Serum albumin≥30g/L;
  7. Life expectancy more than 3 months;
  8. Voluntarily join the study and sign the Informed Consent Form for the study;
  9. Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug.

Exclusion Criteria:

  1. Patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories;
  2. 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 ClassⅠ; Ⅰ-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class Ⅰcardiac dysfunction; Patients with positive urinary protein;
  3. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
  4. 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 haematemesis in the past 2 months;primary lesion in stomach with positive fecal occult blood test (+) should be evaluated by endoscopy and other potential massive haemorrhage conditions evaluated by the investigator;
  5. Abnormal Coagulation (international normalized ratio>1.5, activated partial thromboplastin time>1.5 UNL), with tendency of bleeding;
  6. Associated with central nervous system (CNS) metastases;
  7. Pregnant or lactating women;
  8. Suffering from other malignancies within 5 years;
  9. History of uncontrolled psychotropic drug abuse or mental disorders;
  10. Participated in other clinical study within 4 weeks;
  11. Prior VEGFR inhibitor treatment,such as sorafenib and sunitinib ;
  12. Concomitant disease conditions judged by investigator that may seriously affect subject's safety or affect the study completion;
  13. Other cases that the researcher found ineligible

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): NCT02537171


Contacts
Layout table for location contacts
Contact: Xu jianming, M.D. +861066947178 jmxu2003@yahoo.com

Locations
Layout table for location information
China, Beijing
307 Hospital of PLA Recruiting
Beijing, Beijing, China, 100071
Contact: Xu jianming    +861066947178    jmxu2003@yahoo.com   
Principal Investigator: xu jianming, M.D.         
Sponsors and Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Investigators
Layout table for investigator information
Principal Investigator: Xu jianming, M.D. 307 Hospital of PLA

Layout table for additonal information
Responsible Party: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT02537171    
Other Study ID Numbers: AHEAD-G303
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: August 2015
Keywords provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:
Apatinib
Locally Advanced Gastric Cancer
Metastatic Gastric Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action