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

Sponsor
Capital Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01691664
Collaborator
(none)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Only radiation therapy
  • Other: Radiation therapy plus DC-CIK cellular therapy
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Disease free survival [4 years]

Secondary Outcome Measures

  1. quality of life [Initial assessment → months 1,3,6 and 12]

Other Outcome Measures

  1. Immunological assessment [Initial assessment, months 1,3,6and 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Beijing Shijitan Hospital Beijing Beijing China 100038

Sponsors and Collaborators

  • Capital Medical University

Investigators

  • Principal Investigator: Jun Ren, MD, PhD, Capital Medical University Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Sep 25, 2012
Last Update Posted:
Nov 4, 2019
Last Verified:
Oct 1, 2019
Keywords provided by Jun Ren MD, PhD, Director, Capital Medical University Cancer Center, Capital Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 4, 2019