The Study of Apatinib Plus CIK as the Third Line Therapy for Patients With Advanced Gastric Cancer
The Randomized, Controlled, Multicenter Clinical Trial of Apatinib Plus CIK as the Third Line Therapy for Patients With Advanced Gastric Cancer
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with cytokine-induced killer cell (CIK) vs Apatinib as the third line therapy for patients with advanced gastric cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2015
Longer than P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 24, 2015
CompletedFirst Posted
Study publicly available on registry
June 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2033
February 19, 2016
February 1, 2016
15 years
June 24, 2015
February 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival(OS)
3 months
Secondary Outcomes (1)
Disease-free survival
3 months
Other Outcomes (1)
Adverse events
1 months
Study Arms (2)
Apatinib alone
OTHERApatinib(YN968D1) ,850mg,p.o.,qd,continuous.Patients undergo Apatinib.
Apatinib+CIK
EXPERIMENTALApatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.
Interventions
Cytokine-Induced Killer Cells are used to treat advanced gastric cancer patients with Apatinib.
Advanced gastric cancer patients take Apatinib 850mg qd by mouth.
Eligibility Criteria
You may qualify if:
- Patients who can accept curative operations 18-70 years old
- Histologically confirmed with gastric cancer at stage Ⅳ
- Patients who can accept oral drugs;
- Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.
You may not qualify if:
- Hemoglobin\<8.0 g/dL,White blood cell \<3 X 10\^9/L;Platelet count \<75 X 10\^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
- Known or suspected allergy to the investigational agent or any agent given in association with this trial
- Pregnant or lactating patients
- Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
- Patients who are suffering from serious autoimmune disease
- Patients who had used long time or are using immunosuppressant
- Patients who had active infection
- Patients who are suffering from serious organ dysfunction
- Patients who are suffering from other cancer
- Other situations that the researchers considered unsuitable for this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2015
First Posted
June 30, 2015
Study Start
June 1, 2015
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 1, 2033
Last Updated
February 19, 2016
Record last verified: 2016-02