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Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01691625
Recruitment Status : Recruiting
First Posted : September 25, 2012
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Jun Ren MD, PhD, Capital Medical University

Study Description
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Brief Summary:
The purpose of this study is to show if the adoptive cellular therapy with autologous dendritic cells and cytokine-induced killer cells (CIK) combined with concurrent chemoradiation could improve the quality of life of the patients with locally advanced esophageal cancer, compared with concurrent chemoradiation only.

Condition or disease Intervention/treatment Phase
Esophageal Carcinoma Other: concurrent chemoradiotherapy plus DC-CIK immunotherapy Other: Concurrent chemoradiation only Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer
Study Start Date : September 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: concurrent chemoradiotherapy plus DC-CIK immunotherapy
patients will receive concurrent chemoradiotherapy plur DC-CIK immunotherapy
 Other: concurrent chemoradiotherapy plus DC-CIK immunotherapy

Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.

Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation.

DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition apheresis 3 days before concurrent chemoradiation, and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times between the Chemoradiation intermittent period.
Active Comparator: Concurrent chemoradiation only
patients will receive concurrent chemoradiotherapy only
 Other: Concurrent chemoradiation only

Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.

Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation.


Outcome Measures
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Primary Outcome Measures :
  1. the quality of life [ Time Frame: initial assessment, months 1, 3, 6 and 12 ]

Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Immunological assessment [ Time Frame: baseline, months 1, 3, 6 and 12 ]
    Cytokine secretion and T cell populations are assessed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cytologically or histologically confirmed locally advanced esophageal carcinoma
  • Age: > 18
  • Karnofsky performance status ≥ 70
  • At least one measurable tumor lesions according to the RECIST criteria.
  • Normal functions of heart, lung, liver, kidney and bone marrow
  • Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
  • Informed consent signed

Exclusion Criteria:

  • Patients with metastatic disease in the central nervous system (CNS).
  • Patients who are pregnant or nursing.
  • Patients with poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable
  • Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
  • coexisted morbidities that investigators believed not suitable for chemoradiation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691625


Contacts
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Contact: Jun Ren, MD, PhD 86-10-63926317 renjun9688@yahoo.com

Locations
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China, Beijing
Capital Medical University Cancer Center Recruiting
Beijing, Beijing, China, 100038
Contact: Jun Ren, MD, PhD    86-10-63926317    renjun9688@yahoo.com   
Principal Investigator: Jun Ren, MD, PhD         
Sponsors and Collaborators
Capital Medical University
More Information
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Responsible Party: Jun Ren MD, PhD, Director,Capital Medical University (CMU)Cancer Center,, Capital Medical University
ClinicalTrials.gov Identifier: NCT01691625    
Other Study ID Numbers: JR-01
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: April 2019
Keywords provided by Jun Ren MD, PhD, Capital Medical University:
Locally advanced esophageal carcinoma
DC-CIK
Immunotherapy
Additional relevant MeSH terms:
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Esophageal Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases