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Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With 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: NCT01691664
Recruitment Status : Recruiting
First Posted : September 25, 2012
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jun Ren MD, PhD, Capital Medical University

Study Description
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Brief Summary:
Cytokine-induced killer (CIK) cells show cytolytic activity against tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining Radiation therapy with adoptive cellular therapy after surgery may be more effective than uses radiation therapy alone in treating esophageal cancer.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Radiation: Only radiation therapy Other: Radiation therapy plus DC-CIK cellular therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer
Study Start Date : September 2012
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Only radiation therapy
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 50Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
 Radiation: Only radiation therapy
Patients only radiation therapy after surgery
Experimental: Radiation therapy plus DC-CIK cellular therapy

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 50Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.

DC-CIK cellular therapy:Mononuclear cells were collected aseptically with blood cell separator composition apheresis 3 days before radiation, and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times between the radiation intermittent period.

 Other: Radiation therapy plus DC-CIK cellular therapy
Patients receive radiation therapy plus DC-CIK cellular therapy after surgery


Outcome Measures
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Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. quality of life [ Time Frame: Initial assessment → months 1,3,6 and 12 ]

Other Outcome Measures:
  1. Immunological assessment [ Time Frame: Initial assessment, months 1,3,6and 12 ]

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 esophageal carcinoma
  • Tumor extension beyond muscularis propria and/or nodal involvement without evidence of M1 disease
  • Prior en bloc resection, with curative intent, of all known tumor
  • No metastatic disease
  • Age: > 18
  • Karnofsky performance status ≥ 70
  • At least 3 weeks since prior surgery
  • 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
  • All patients must be evaluated by a radiation oncologist prior to enrollment to ensure patient is appropriate for radiotherapy
  • Informed consent signed

Exclusion Criteria:

  • Patients with metastatic disease.
  • Patients who are pregnant or nursing.
  • Patients with poor bone marrow, liver and kidney functions, which would make radiation therapy intolerable
  • Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
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): NCT01691664


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

Locations
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China, Beijing
Beijing Shijitan Hospital Recruiting
Beijing, Beijing, China, 100038
Contact: Jun Ren, MD, PhD    86-10-63926317      
Sponsors and Collaborators
Capital Medical University
Investigators
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Principal Investigator: Jun Ren, MD, PhD Capital Medical University Cancer Center
More Information
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Responsible Party: Jun Ren MD, PhD, Director, Capital Medical University Cancer Center, Capital Medical University
ClinicalTrials.gov Identifier: NCT01691664    
Other Study ID Numbers: JR-02
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Keywords provided by Jun Ren MD, PhD, Capital Medical University:
Esophageal Cancer
DC-CIK
immunotherapy
cellular therapy
radiation therapy
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases