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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01691664

Enrollment

Registered

2012-09-25

Start date

2012-09-30

Completion date

2022-06-30

Last updated

2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer, DC-CIK, immunotherapy, cellular therapy, radiation therapy

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.

Interventions

RADIATIONOnly radiation therapy

Patients only radiation therapy after surgery

OTHERRadiation therapy plus DC-CIK cellular therapy

Patients receive radiation therapy plus DC-CIK cellular therapy after surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Disease free survival	4 years

Secondary

Measure	Time frame
quality of life	Initial assessment → months 1,3,6 and 12

Other

Measure	Time frame
Immunological assessment	Initial assessment, months 1,3,6and 12

Countries

China

Contacts

Primary ContactJun Ren, MD,PhD

renjun9688@yahoo.com86-10-63926317

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026