Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/KCT0002944
KCT0002944Recruiting未知

Study of immunologic responses and safety of autologous dendritic cells in advanced gastric cancer patients following curative resection

Dongnam Institute of Radiological & Medical Sciences0 sites50 target enrollmentStarted: TBDLast updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Trial Snapshot

Phase
未知
Status
Recruiting
Enrollment
50
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional Study

Eligibility Criteria

Ages
20(Year) to o Limit (—)
Sex
All

Inclusion Criteria

  • •? Males or females aged 20 years or older
  • •? Patients who have undergone curative resection after being diagnosed histologically with non-metastatic gastric adenocarcinoma (stage II–III)
  • •? Patients with an autologous (frozen) tumor tissue sample for gastric cancer
  • •? Patients who have completed curative resection and adjuvant treatment for advanced gastric cancer within the last 3–12 weeks
  • •- Standard adjuvant treatment: S-1 therapy or XELOX therapy
  • •S-1 therapy: S-1 administered twice per day at the following doses for Days 1–28, repeated at 6-week intervals for 1 year
  • •<1.25 m2: 40 mg per dose,
  • •=1.25 m2 and <1.5 m2: 50 mg per dose,
  • •=1.5 m2: 60 mg per dose.
  • •XELOX therapy: Capecitabine 1000 mg/m2 twice per day for days 1–14
  • •Oxaliplatin 130 mg/m2 on day 1, repeated at 3-week intervals for 6 months
  • •? Among patients unable to receive adjuvant therapy after curative resection for advanced gastric cancer, those who received curative resection within the last 3–12 weeks
  • •- Elderly patients (>70 years old) who refused adjuvant therapy
  • •- Patients contraindicated for the standard adjuvant chemotherapy agents S-1 or XELOX (capecitabine, oxaliplatin)
  • •? Contraindications for S-1: Patients with a history of severe S-1 hypersensitivity, patients currently being administered other fluoropyrimidines, patients currently being administered flucytosine
  • •? Contraindications for capecitabine: Patients with a history of capecitabine hypersensitivity, patients who show a severe reaction to fluoropyrimidines or fluoruracil hypersensitivity, patients taking combination sorivudine/brivudine, patients with DPD deficiency, patients taking combination tegafur/gimeracil/oteracil potassium currently or who stopped in the last 7 days
  • •? Contraindications for oxaliplatin: Patients with a history of hypersensitivity to oxaliplatin or other platinum-containing drugs, patients with peripheral sensory neuropathy showing functional injury before the first cycle
  • •? Patients with an ECOG score of 0–2 for performance status
  • •? Patients satisfying the following conditions
  • •- Hematologic function: WBC count =3,000/µL, ANC =1,500/µL,
  • •- Platelet count =75,000/µL, hemoglobin =9.0 mg/dL
  • •- Hepatic function: bilirubin =1.5-fold the normal values, ALT and AST =2.5-fold the normal values
  • •- Renal function: creatinine =1.5 mg/dL
  • •? Among fertile patients, those consenting to the use of appropriate contraception
  • •? Among female patients who may be patient, those showing a negative result in urine HCG tests 7 days before registration
  • •? Individuals who sign the participant consent form and consent to the trial and follow-up procedures

Exclusion Criteria

  • •? Patients who have received other types of immunotherapy in the last year
  • •? Patients for whom the planned dose of test drug cannot be prepared because of difficulty in obtaining a sufficient amount of autologous tumor tissue
  • •? Patients with uncontrolled autoimmune disease or severe internal disease (severe infection, heart disease, etc.)
  • •? Patients with uncontrolled central nervous system or psychiatric disability
  • •? Patients who have been diagnosed with multiple active primary cancer in the last 5 years, excluding properly treated cervical carcinoma in situ, basal or squamous cell carcinoma of the skin, and thyroid cancer
  • •? HIV-positive patients
  • •? Patients who have been treated for tuberculosis within the last year
  • •? Pregnant or breastfeeding women
  • •? Patients who are regularly administered corticosteroids (or equivalent; excluding medication for acute hypersensitivity reaction, or patients who are being administered a low dose (=20 mg methylprednisolone or equivalent) for at least 6 months before being administered the test drug in this study)
  • •? Patients contraindicated for or requiring caution when taking cyclophosphamide
  • •- Patients being administered pentostatin; patients with a history of infectious disease, severe bone marrow depression, cystitis, urinary tract obstruction, or hypersensitivity to the drug’s ingredient; pregnant or breastfeeding women; and patients with severe liver or kidney dysfunction
  • •- Patients with varicella
  • •? Patients who have been judged to be unsuitable as a clinical trial participant by another researcher
  • •- Patients who are certain to drop out of the study or who are unavailable for long-term follow-up for any of the following reasons: psychological, social, family, or geographical reasons, or difficulty adhering to the proper follow-up procedures or the clinical study plan
  • •- Patients with uncontrolled hepatitis, chronic liver disease, or diabetes
  • •- Patients who were considered to be unsuited to participating in this trial by their attending physician

Investigators

Similar Trials

Recruiting
Not Applicable
Immunological response and safety of autologous dendritic cells in triple-negative breast cancer (TNBC) patients who have received curative surgery after neoadjuvant chemotherapy(NCT).Neoplasms
KCT0002931Dongnam Institute of Radiological & Medical Sciences50
Active, not recruiting
Phase 1
Study on an Investigational Yellow Fever Vaccine Compared with Stamaril in Adults in Europe and AsiaMedDRA version: 20.0Level: PTClassification code: 10048240Term: Yellow fever Class: 100000004862Yellow fever
CTIS2022-502047-35-00Sanofi Pasteur690
Active, not recruiting
Phase 1
Study on an Investigational Yellow Fever Vaccine Compared with Stamaril in Adults in Europe and Asia
EUCTR2020-005566-33-DESanofi Pasteur690
Active, not recruiting
Phase 1
Study on an Investigational Yellow Fever Vaccine Compared with Stamaril in Adults in Europe and AsiaPrevention of yellow feverMedDRA version: 20.0Level: PTClassification code 10048240Term: Yellow feverSystem Organ Class: 10021881 - Infections and infestations
EUCTR2020-005566-33-FISanofi Pasteur690
Active, not recruiting
Phase 1
Study on an Investigational Yellow Fever Vaccine Compared with Stamaril in Adults in Europe and AsiaPrevention of yellow feverMedDRA version: 20.0Level: PTClassification code 10048240Term: Yellow feverSystem Organ Class: 10021881 - Infections and infestations
EUCTR2020-005566-33-FRSanofi Pasteur690