Study of S-1 Plus DC-CIK for Patients With Advanced Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Gastric cancer, S-1, DC-CIK
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: S-1 plus DC-CIK
Type: Other
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the antitumor effect and safety of clinical effectiveness S-1 plus dendritic cell activated Cytokine induced killer treatment (DC-CIK) for advanced gastric cancer.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically/cytologically confirmed recurrent or metastatic gastric or esophagogastric junctional adenocarcinoma

- Between 18 and 80 years old

- Capable of oral intake

- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria

- Karnofsky Performance Status (KPS) ≥ 70%

- Normal functions of heart, lung and bone marrow

- Adequate hematological profile: Hemoglobin ≥ 9.0 g/dL Absolute granulocyte count ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3

- Adequate hepatic function Total bilirubin level≤ 3.0 times the upper limit of normal (ULN) Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN

- Adequate renal function(normal serum creatinine level)

- A life expectancy≥ 2 months

- Informed consent signed

Exclusion Criteria:

- Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study

- Any radiotherapy or surgery within the previous 4 weeks

- Symptomatic brain metastasis not controlled by corticosteroids

- Bone marrow metastasis

- Active infection

- Serious complications

- Receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid.

- Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy

- Ineligible for the study at the discretion of investigators
Location
Capital Medical University Cancer Center
Beijing, Beijing, China
Status: Recruiting
Contact: Jun Ren, MD,PhD - 86-10-63926317 - renjun9688@yahoo.com
Start Date
February 2013
Completion Date
December 2017
Sponsors
Capital Medical University
Source
Capital Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page