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NCT Number: NCT01783951

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Capital Medical University Cancer Center

Beijing, Beijing Municipality, 100038, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DC-CIK

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

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

Drug

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

Primary outcomes

  1. Progression free survival（PFS）

    Time frame: 4 years

Secondary outcomes

  1. Overall survival

    Time frame: 4 years

  2. Response rate

    Time frame: Every 6 weeks

  3. Adverse Events

    Time frame: Every 3 weeks

  4. Quality of life

    Time frame: 6 weeks

    Evaluation of quality of life will be performed every 2 cycles (6 weeks) from baseline to the end of treatment.

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Collaborators

  • Duke University
  • Geneplus-Beijing Co. Ltd.

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Feb 5, 2013
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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