NCT02504229

Brief Summary

This study evaluates the therapeutic effects of autologous dendritic cells co-cultured with cytokine-induced killer cells (DC-CIK) combined with S-1 ((Tegafur, Gimeracil, and Oteracil Potassium) and oxaliplatin adjuvant chemotherapy in locally advanced unresectable or metastaticgastric cancer. Half of participants will receive DC-CIK combined with S-1 and oxaliplatin adjuvant chemotherapy,while the other half will receive S-1 and oxaliplatin adjuvant chemotherapy served as controls.

Trial Health

55
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Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2 gastric-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

3.7 years

First QC Date

July 20, 2015

Last Update Submit

July 20, 2015

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    6 weeks

Study Arms (2)

Chemotherapy+DC-CIK

EXPERIMENTAL

Combined treatment group:mononuclear cells were obtained aseptically with blood cell separator composition spheresis 1 day before SOX program chemotherapy, cultured DC-CIK cells. SOX program was acted on Day 2. Cells were cultured 14d,2 times back to the patient.A 21d was a cycle, then evaluated the therapeutic effect after two cycles.

Biological: autologous dendritic cells co-cultured with cytokine-induced killer cellsDrug: Gimeracil and Oteracil Porassium CapsulesDrug: Oxaliplatin

Chemotherapy alone

ACTIVE COMPARATOR

Chemotherapy: two groups were treated with SOX program,specific drugs:Venoclysis of oxaliplatin 130mg/㎡;Day 1; Tegafur,Gimeracil and Oteracil Porassium Capsules 80mg/㎡/d,two oral/d;Day 1 to 12; 21d as one cycle of treatment, evaluated the therapeutic effect after two cycles.

Drug: Gimeracil and Oteracil Porassium CapsulesDrug: Oxaliplatin

Interventions

autologous dendritic cells co-cultured with cytokine-induced killer cellsBIOLOGICAL
Chemotherapy+DC-CIK
Gimeracil and Oteracil Porassium CapsulesDRUG
Chemotherapy aloneChemotherapy+DC-CIK
OxaliplatinDRUG
Also known as: Eloxatin
Chemotherapy aloneChemotherapy+DC-CIK

Eligibility Criteria

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

You may qualify if:

  • Age\>18y;
  • ECOG physical status 0-1;
  • The histologic diagnosis of stomach/gastroesophageal junction adenocarcinoma;
  • According to the RECIST 1.1 standard with measurable or evaluable lesion;
  • Accept swallow oral drug;
  • WBC≧4.0×10\^9/L;ALC≧0.8×10\^9/L;ANC≧1.5×10\^9/L;PLT≧100×10\^9/L;ALT,AST≦2.5 times of the normal limit;ALP≦2.5 times of the normal limit;TBIL﹤1.5 times of the normal limit;SCr﹤1 times of the normal limit;ALB≧30g/L;
  • The expected survival time of more than 3 months;
  • good compliance;
  • Provide written informed consent.

You may not qualify if:

  • Vital organs (heart,liver,kidney) function is serious dysfunction;
  • Patients received organ transplantation;
  • Patients with other malignant tumors or have occurred brain metastasis;
  • Patients with history of autoimmune disease;
  • Patients in pregnancy or breast-feeding period(women of child-bearing age need to check pregnancy test);
  • Patients with acute infection disease or in chronic active stage;
  • Patients with clear history of drug allergy or belong to allergic constitution;
  • Patients received chemotherapy,radiation therapy, immunosuppressive drugs (cyclosporine A,etc.) or other immune treatment in 4 weeks;
  • Patients received other clinical trials in 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences Tumor Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (1)

  • Ma X, Peng L, Wang J, Gao L, Zhang W, Lu X, Liu J, Yang L. Autologous CIK cells combined with chemotherapy as the first-line treatment for locally advanced or metastatic gastric cancer is safe and feasible. Front Immunol. 2023 Nov 1;14:1267369. doi: 10.3389/fimmu.2023.1267369. eCollection 2023.

    PMID: 38022664DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

gimeracilOxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • jinwan Wang

    Chinese Academy of Medical Sciences Tumor Hospital

    PRINCIPAL INVESTIGATOR

  • lin yang

    Chinese Academy of Medical Sciences Tumor Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingwei liu, PhD

CONTACT

13241238766ljwgirl361@163.com

Tsai Ting Huang

CONTACT

18610571563huangct@biohealthcare.com.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2015

First Posted

July 21, 2015

Study Start

November 1, 2014

Primary Completion

July 1, 2018

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

CN(1)