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Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Only radiation therapy
Radiation therapy plus DC-CIK cellular therapy
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal Cancer, DC-CIK, immunotherapy, cellular therapy, radiation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Shijitan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Only radiation therapy

Radiation therapy plus DC-CIK cellular therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Disease free survival

Secondary Outcome Measures

quality of life

Full Information

First Posted
September 18, 2012
Last Updated
October 31, 2019
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01691664
Brief Title
Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer
Official Title
Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Esophageal Cancer, DC-CIK, immunotherapy, cellular therapy, radiation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Only radiation therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Radiation therapy plus DC-CIK cellular therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Only radiation therapy
Intervention Description
Patients only radiation therapy after surgery
Intervention Type
Other
Intervention Name(s)
Radiation therapy plus DC-CIK cellular therapy
Intervention Description
Patients receive radiation therapy plus DC-CIK cellular therapy after surgery
Primary Outcome Measure Information:
Title
Disease free survival
Time Frame
4 years
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
Initial assessment → months 1,3,6 and 12
Other Pre-specified Outcome Measures:
Title
Immunological assessment
Time Frame
Initial assessment, months 1,3,6and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Ren, MD,PhD
Phone
86-10-63926317
Email
renjun9688@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Ren, MD, PhD
Organizational Affiliation
Capital Medical University Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Shijitan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Ren, MD, PhD
Phone
86-10-63926317

12. IPD Sharing Statement

Learn more about this trial

Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer

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