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NCT01691625 Clinical Trial

Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer

Esophageal Carcinoma Clinical Trial

Official title:
Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01691625
Other study ID # JR-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2012
Est. completion date December 2021

Study information
Verified date February 2024
Source Capital Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to show if the adoptive cellular therapy with autologous dendritic cells and cytokine-induced killer cells (CIK) combined with concurrent chemoradiation could improve the quality of life of the patients with locally advanced esophageal cancer, compared with concurrent chemoradiation only.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
China Capital Medical University Cancer Center Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Other Immunological assessment Cytokine secretion and T cell populations are assessed. baseline, months 1, 3, 6 and 12
Primary the quality of life initial assessment, months 1, 3, 6 and 12
Secondary progression-free survival 1 year
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