Study of S-1 Plus DC-CIK for Patients With Advanced Gastric Cancer

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the antitumor effect and safety of clinical effectiveness dendritic cell activated Cytokine induced killer treatment (DC-CIK) plus S-1 based chemotherapy for advanced gastric cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Capital Medical University
• Collaborators: Duke University; Geneplus-Beijing Co. Ltd.
• Treatments: Cisplatin

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