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Apatinib for the Elderly Advanced 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03104283
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Jiuda Zhao, Affiliated Hospital of Qinghai University

Brief Summary:
The purpose of our study is to assess the efficacy and safety of apatinib in elderly advanced gastric cancer patients, and to find the relationship between the expression of VEGFR-2 and efficacy of apatinib treatment.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Apatinib Phase 2

Detailed Description:

The trial is funded by Chinese Society of Clinical Oncology-Beijing Xisike Clinical Oncology Research Fundation. The trial is prepared to be registered on the clinicaltrail.gov.

Quality assurance plan: Every participant is enrolled or excluded by two practiced investigators. And two investigators participate in all steps of the trail, including the record of the data, which is compared by the investigators. If the data is consistent, the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the staff of research and financial department of Affliated Hospital of Qinghai University.

Data check: The investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.

Source data verification: The investigators assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms.

Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information, and normal ranges if relevant.

Standard Operating Procedures to address registry operations and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. All registry operations would be done according to specific steps, and by two practiced investigators.

Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. According to the formula to differ advantages and disadvantages, the investigators need at least 60 participants to take part in the trail. The investigators can recruit about 20 participants every year according to previous experiences, so the investigators should recruit at least for three years.

Plan for missing data: The investigators would collect as much data as possible, and the investigators exclude the participants who cannot cooperate on recruitment. And the investigators manage situations according to statistical principles where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results.

Statistical analysis plan: Statistical analyses would be performed by using SPSS software, version 13.0 (SPSS Inc., IL, USA). Survival analysis would be performed using Kaplan-Meier methodology. Fisher's exact test would be used to analyze the efficacy of treatment. Cox proportional hazards model would be used for multivariate analysis. The level of significance is defined as P < 0.05.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single-arm, Phase Ⅱ Clinical Trial of Apatinib Monotherapy in Elderly Patients With Advanced Gastric Cancer(GC)
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Apatinib Group
take apatinib orally (425mg/d, once a day, continuously )
Drug: Apatinib
take apatinib orally until disease progression or appearance of unbearable toxicity
Other Name: Apatinib group




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 1 year ]
    PFS was defined to be the time from registration to the date of disease progress sion or death resulting from any cause.


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 1 year ]
    ORR was defined as the proportion of eligible patients who achieved a confirmed complete response(CR )or partial response (PR) by RECIST 1.1 criteria evaluated by the investigators.

  2. Disease control rate (DCR) [ Time Frame: 1 year ]
    DCR was defined as the proportion of patients who achieved CR, PR and stable disease (SD) for at least 8 weeks.

  3. Overall survival (OS) [ Time Frame: 1 year ]
    OS was defined to be the time from registration to the date of death resulting from any cause or the last follow-up visit.



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.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Elderly patients (aged ≥ 60 years) with histologically confirmed advanced adenocarcinoma of the stomach or gastroesophageal junction;
  2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
  3. Progression with or intolerance to one or more lines of chemotherapy;
  4. At least one measurable lesion as defined by RECIST 1.1;
  5. With acceptable hematologic, cardiac, hepatic, pulmonary and renal function;
  6. Can take apatinib orally;
  7. Estimated life expectancy ≥ 3 months.

Exclusion Criteria:

  1. Patients cannot take apatinib orally for any reason;
  2. Patients with uncontrolled central nervous system (CNS) metastases;
  3. Patients with massive hydrothorax or ascites;
  4. Proteinuria 2+ or 24-hour urinary protein ≥ 1g;
  5. Newly-happened traumatism or pathological fracture;
  6. Estimated life expectancy ˂ 3 months;
  7. Received chemotherapy in the past 28 days before enrollment;
  8. Patients with uncontrolled blood pressure on medication (≥ 140/90 mmHg);
  9. Patients with bleeding tendency, receiving thrombolytics or anticoagulants, receiving intravenous antibiotic treatment, had received bevacizumab or other VEGF TKIs before, or with other primary malignancy (except basal cell skin cancer or cervical carcinoma in situ).

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): NCT03104283


Contacts
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Contact: Jiuda Zhao, M.D. +869716162732 jiudazhao@126.com

Locations
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China, Qinghai
Affiliated Hospital of Qinghai University Recruiting
Xining, Qinghai, China, 810000
Contact: Jiuda Zhao, M.D.    +869716162732    jiudazhao@126.com   
People's Hospital of Qinghai Province Not yet recruiting
Xining, Qinghai, China, 810000
Contact: Jie Kan, M.D    +8613897584590    kanying1208@126.com   
Qinghai Red Cross Hospital Not yet recruiting
Xining, Qinghai, China, 810000
Contact: Yu Zhang, M.D    +8613709722601    zhang_yv@163.com   
Sponsors and Collaborators
Affiliated Hospital of Qinghai University
Investigators
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Principal Investigator: Jiuda Zhao, M.D. Affiliated Hospital of Qinghai University
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Responsible Party: Jiuda Zhao, Professor, Affiliated Hospital of Qinghai University
ClinicalTrials.gov Identifier: NCT03104283    
Other Study ID Numbers: AHQU-2017001
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiuda Zhao, Affiliated Hospital of Qinghai University:
apatinib
gastric cancer
elderly patients
Additional relevant MeSH terms:
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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