Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer
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ClinicalTrials.gov Identifier: NCT01691664 |
Recruitment Status :
Recruiting
First Posted : September 25, 2012
Last Update Posted : November 4, 2019
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Condition or disease | Intervention/treatment | Phase |
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Esophageal Cancer | Radiation: Only radiation therapy Other: Radiation therapy plus DC-CIK cellular therapy | Not Applicable |
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 |

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.
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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 |
- Disease free survival [ Time Frame: 4 years ]
- quality of life [ Time Frame: Initial assessment → months 1,3,6 and 12 ]
- Immunological assessment [ Time Frame: Initial assessment, months 1,3,6and 12 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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
Contact: Jun Ren, MD,PhD | 86-10-63926317 | renjun9688@yahoo.com |
China, Beijing | |
Beijing Shijitan Hospital | Recruiting |
Beijing, Beijing, China, 100038 | |
Contact: Jun Ren, MD, PhD 86-10-63926317 |
Principal Investigator: | Jun Ren, MD, PhD | Capital Medical University Cancer Center |
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 |
Esophageal Cancer DC-CIK immunotherapy cellular therapy radiation therapy |
Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |