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

Gastric Cancer Clinical Trial

Official title:

Autologous Dendritic Cell-cytokine Induced Killer Cell Immunotherapy Combined With S-1 Based Chemotherapy in Patients With Advanced Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783951
• Other study ID #: S1+DC CIK- G
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 1, 2013
• Est. completion date: June 1, 2018

Study information

• Verified date: July 2018
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 1, 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Biological:
• DC-CIK
Patients will be receive DC-CIK cell therapy at days 15, 17 and 19 per cycle and received cycles of treatment once every 21 days.

Drug:
• S-1
The dose of S-1 is determined according to the body surface area as follows: <1.25 m2, 40 mg; 1.25 to <1.5 m2, 50 mg; and =1.5 m2, 60 mg, given twice daily after meals for 14 days followed by 7 days rest.
• Cisplatin
Cisplatin is administered at 75 mg/m2 intravenously over 1 to 3 hours every 21 days.

Locations

Country	Name	City	State
China	Capital Medical University Cancer Center	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Capital Medical University	Duke University, Geneplus-Beijing Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival(PFS)		4 years
Secondary	Overall survival		4 years
Secondary	Response rate		Every 6 weeks
Secondary	Adverse Events		Every 3 weeks
Secondary	Quality of life	Evaluation of quality of life will be performed every 2 cycles (6 weeks) from baseline to the end of treatment.	6 weeks