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

NCT ID: NCT01783951

Last Updated: 2018-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-01
• Study Completion Date: 2018-06-01

Brief 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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DC-CIK plus S-1 based chemotherapy

Patients will be receive S-1 based chemotherapy, including S-1 plus cisplatin or S-1 alone. Meanwhile those patients will receive DC-CIK cell therapy at days 15, 17 and 19 per cycle and received cycles of treatment once every 21 days.Treatment was continued until disease progression, unacceptable toxic effects, or the withdrawal of consent.

Group Type: EXPERIMENTAL

DC-CIK

Intervention Type: BIOLOGICAL

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.

S-1

Intervention Type: DRUG

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

Intervention Type: DRUG

Cisplatin is administered at 75 mg/m2 intravenously over 1 to 3 hours every 21 days.

S-1 based chemotherapy

Patients will be receive S-1 based chemotherapy, including S-1 plus cisplatin or S-1 alone.Cycles were repeated every 21 days. Treatment was continued until disease progression, unacceptable toxic effects, or the withdrawal of consent.

Group Type: ACTIVE_COMPARATOR

S-1

Intervention Type: DRUG

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

Intervention Type: DRUG

Cisplatin is administered at 75 mg/m2 intravenously over 1 to 3 hours every 21 days.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: DRUG

Cisplatin

Cisplatin is administered at 75 mg/m2 intravenously over 1 to 3 hours every 21 days.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Geneplus-Beijing Co. Ltd.

INDUSTRY

Sponsor Role: collaborator

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jun Ren MD, PhD

Director,Capital Medical University (CMU)Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Capital Medical University Cancer Center

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

S1+DC CIK- G

Identifier Type: -

Identifier Source: org_study_id