Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer
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ClinicalTrials.gov Identifier: NCT01691625 |
Recruitment Status :
Recruiting
First Posted : September 25, 2012
Last Update Posted : January 3, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Esophageal Carcinoma | Other: concurrent chemoradiotherapy plus DC-CIK immunotherapy Other: Concurrent chemoradiation only | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: concurrent chemoradiotherapy plus DC-CIK immunotherapy
patients will receive concurrent chemoradiotherapy plur DC-CIK immunotherapy
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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. |
- the quality of life [ Time Frame: initial assessment, months 1, 3, 6 and 12 ]
- progression-free survival [ Time Frame: 1 year ]
- Immunological assessment [ Time Frame: baseline, months 1, 3, 6 and 12 ]Cytokine secretion and T cell populations are assessed.

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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 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

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
Contact: Jun Ren, MD, PhD | 86-10-63926317 | renjun9688@yahoo.com |
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 |
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 |
Locally advanced esophageal carcinoma DC-CIK Immunotherapy |
Esophageal Neoplasms Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |