NCT01783951

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_1 gastric-cancer

Timeline
Completed

Started Feb 2013

Longer than P75 for phase_1 gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

5 years

First QC Date

February 1, 2013

Last Update Submit

July 18, 2018

Conditions

Gastric Cancer

Keywords

Gastric cancerS-1DC-CIKT cell

Outcome Measures

Primary Outcomes (1)

  • Progression free survival（PFS）

    4 years

Secondary Outcomes (4)

  • Overall survival

    4 years

  • Response rate

    Every 6 weeks

  • Adverse Events

    Every 3 weeks

  • Quality of life

    6 weeks

Study Arms (2)

DC-CIK plus S-1 based chemotherapy

EXPERIMENTAL

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.

Biological: DC-CIKDrug: S-1Drug: Cisplatin

S-1 based chemotherapy

ACTIVE COMPARATOR

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.

Drug: S-1Drug: Cisplatin

Interventions

DC-CIKBIOLOGICAL

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.

DC-CIK plus S-1 based chemotherapy
S-1DRUG

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.

DC-CIK plus S-1 based chemotherapyS-1 based chemotherapy
CisplatinDRUG

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

DC-CIK plus S-1 based chemotherapyS-1 based chemotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Medical University Cancer Center

Beijing, Beijing Municipality, 100038, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination)Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director,Capital Medical University (CMU)Cancer Center

Study Record Dates

First Submitted

February 1, 2013

First Posted

February 5, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2018

Study Completion

June 1, 2018

Last Updated

July 19, 2018

Record last verified: 2018-07

Locations

CN(1)