Active, not recruitingNCT02485015Updated Feb 19, 2016

The Study of Apatinib Plus CIK as the Third Line Therapy for Patients With Advanced Gastric Cancer

A Phase 2 interventional study of Cytokine-Induced Killer Cells and Apatinib in Stomach Neoplasms, sponsored by The First People's Hospital of Changzhou. Active, not recruiting. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-02-19.

Sponsored by The First People's Hospital of Changzhou · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 80
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: Female

Study 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.

Read the detailed description

400 patients with stage Ⅳ Gastric Cancer,who had received surgery and chemotherapy,will be randomly divided into group A（receive Apatinib and CIK treatment ) or group B（just receive Apatinib),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only Apatinib (continuous) .

Conditions studied

Stomach Neoplasms

Browse trials for

Stomach Neoplasms 2,914

Keywords

CIK
gastric cancer
Apatinib

In context

Stomach Neoplasms

2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.

This study's enrollment of 80 is above the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

The First People's Hospital of Changzhou is the lead sponsor of 28 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 80 participants (actual)

Study arms

Other
Apatinib alone
Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.Patients undergo Apatinib.
Drug: Apatinib
Experimental
Apatinib+CIK
Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.
Biological: Cytokine-Induced Killer Cells · Drug: Apatinib

Interventions

BiologicalCytokine-Induced Killer Cells
Cytokine-Induced Killer Cells are used to treat advanced gastric cancer patients with Apatinib.
Also known as: CIK
DrugApatinib
Advanced gastric cancer patients take Apatinib 850mg qd by mouth.
Also known as: YN968D1

What researchers measure

Primary outcomes

Overall Survival(OS)
Time frame: 3 months

Secondary outcomes

Disease-free survival
Time frame: 3 months

Other outcomes

Adverse events
Time frame: 1 months

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02485015
Lead sponsor: The First People's Hospital of Changzhou
Responsible party: Sponsor
First posted: Jun 30, 2015
Start date: Jun 2015
Primary completion: Jun 2030 (estimated)
Completion: Jun 2033 (estimated)
Last update: Feb 19, 2016

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Cytokine-Induced Killer Cells

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