Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
Esophageal Cancer, DC-CIK, immunotherapy, cellular therapy, radiation therapy
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Only radiation therapy Type: Radiation
Name: Radiation therapy plus DC-CIK cellular therapy Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Beijing Shijitan Hospital
Beijing, Beijing, China
Status: Recruiting
Contact: Jun Ren, MD, PhD - 86-10-63926317
Start Date
September 2012
Completion Date
June 2017
Sponsors
Capital Medical University
Source
Capital Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page