- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02693236
DC Vaccine Combined With CIK Cells in Patients With Esophagus Cancer
February 23, 2016 updated by: Affiliated Hospital to Academy of Military Medical Sciences
Clinical Research of Genetically Modified Dendritic Cells in Combination With Cytokine-induced Killer Cell Treatment in Middle and Advanced Esophagus Cancer Patients
The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells(DC) combined with cytokine-induced killer (CIK) cells in patients with advanced esophagus cancer.
Experimental recombinant adenovirus coded mRNA including MUC1 and Survivin that transfected DC, which are used for DC-based immunotherapy.
Based on the results of our previously performed preclinical study with DC vaccine combined with CIK cells, the researcher plan to perform the clinical trial.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China
- Affiliated Hospital to Academy of Military Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histopathologically confirmed diagnosis of esophagus cancer
- Age >18 years at time of consent
- Received standardized treatment of Small-Cell Lung Cancer
- Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
- KPS (Karnofsky performance scale) >60
- Patient's written informed consent
- No severe viral or bacterial infections
- Predicted survival >3 months
Exclusion Criteria:
- Serious dysfunction of vital organs(heart, liver or kidney)
- History of autoimmune diseases
- Pregnant and breast-feeding patient
- Active or chronic infectious diseases
- History of allergy or hypersensitivity to study product excipients
- Currently participating in another clinical trial
- Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks
- Clinically relevant diseases or infections (HBV, HCV, HIV)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: adenovirus-transfected autologous DC vaccine plus CIK cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
objective rate response (CR+PR) as measured by RECIST criteria
Time Frame: Time Frame: 4 weeks after DC/CIK treatment
|
Time Frame: 4 weeks after DC/CIK treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of participants with adverse events
Time Frame: Time Frame: 3 days within DC/CIK treatment
|
Time Frame: 3 days within DC/CIK treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Anticipated)
August 1, 2016
Study Completion (Anticipated)
November 1, 2016
Study Registration Dates
First Submitted
February 23, 2016
First Submitted That Met QC Criteria
February 23, 2016
First Posted (Estimate)
February 26, 2016
Study Record Updates
Last Update Posted (Estimate)
February 26, 2016
Last Update Submitted That Met QC Criteria
February 23, 2016
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 307-CTC-DC/CIK-EC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Esophagus Cancer
-
Mayo ClinicFred Hutchinson Cancer CenterCompletedBarrett's Esophagus With High Grade Dsyplasia | Early Esophageal CancerUnited States
-
University of Alabama at BirminghamAventis Pharmaceuticals; Pharmacia and UpjohnCompletedEsophageal Cancer | Cancer of the Esophagus | Esophageal Neoplasm | Esophagus Cancer | Cancer of EsophagusUnited States
-
University Hospitals, LeicesterNational Institute for Health Research, United Kingdom; University of LeicesterCompletedBarretts Esophagus | Esophageal High-Grade Intraepithelial Neoplasia | Esophageal Cancer Stage IUnited Kingdom
-
University Medical Center GroningenCompletedEsophageal Cancer | Barrett Esophagus | Dysplasia in Barrett EsophagusNetherlands
-
Academisch Medisch Centrum - Universiteit van Amsterdam...University Medical Center Groningen; UMC Utrecht; Erasmus Medical Center; Catharina... and other collaboratorsNot yet recruitingEsophageal Cancer | Barrett Adenocarcinoma | Barretts Esophagus With Dysplasia
-
Johns Hopkins UniversityAmerican Society for Gastrointestinal Endoscopy; Pentax Medical CorporationCompletedBarrett's Esophagus, Esophageal Intraepithelial NeoplasiaUnited States, Germany
-
City of Hope Medical CenterRecruitingEsophageal Cancer | Esophageal Neoplasms | Gastroesophageal Reflux | Barrett Esophagus | Esophageal Adenocarcinoma | Reflux Disease | Barretts Esophagus With High Grade Dysplasia | Barrett Adenocarcinoma | Esophagus Cancer | Barrett's Esophagus Without Dysplasia | Barretts Esophagus With Dysplasia | Esophagus... and other conditionsUnited States
-
Mayo ClinicWithdrawnEsophageal Cancer | Cancer of the Esophagus | Esophagus Cancer | Cancer of Esophagus | Esophagus Neoplasm | Neoplasms, EsophagealUnited States
-
Pentax MedicalCompletedEsophageal Cancer | Barrett's EsophagusUnited States, Netherlands
-
University of Colorado, DenverUniversity of California, Los Angeles; H. Lee Moffitt Cancer Center and Research... and other collaboratorsRecruitingTREAT-BE Study (Treatment With Resection and Endoscopic Ablation Techniques for Barrett's Esophagus)Esophageal Cancer | Barrett's EsophagusUnited States
Clinical Trials on adenovirus-transfected autologous DC vaccine plus CIK cells
-
Affiliated Hospital to Academy of Military Medical...UnknownSmall- Cell Lung Cancer
-
Affiliated Hospital to Academy of Military Medical...Unknown
-
Affiliated Hospital to Academy of Military Medical...UnknownHigh-risk Soft Tissue SarcomaChina
-
Chang Gung Memorial HospitalRecruiting
-
University of PittsburghTerminatedSquamous Cell Carcinoma of the Head and Neck | Primary Advanced Carcinoma of the Oral Cavity or OropharynxUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)CompletedAdenovirus CCL-21 Transduced MART-1/gp100/Tyrosinase/NY-ESO-1 Peptide-Pulsed Dendritic Cells MaturedMelanoma (Skin)United States
-
Sun Yat-sen UniversityUnknownStage IV Nasopharyngeal CarcinomaChina
-
Istituto Scientifico Romagnolo per lo Studio e...RecruitingGlioblastoma | VaccinationItaly
-
University of FloridaOligo Nation, IncNot yet recruitingRecurrent Oligodendroglioma | Progressive OligodendrogliomaUnited States
-
Juan C. Ramos, MDWithdrawnAcute Lymphoblastic Leukemia | Acute Myelogenous Leukemia | Refractory Leukemia | Adult T-Cell Leukemia/Lymphoma | Relapsed LeukemiaUnited States