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

Capital Medical University

Status: Unknown

Conditions: Esophageal Cancer

Treatments: Radiation: Only radiation therapy; Other: Radiation therapy plus DC-CIK cellular therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01691664

JR-02

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Only radiation therapy

Active Comparator group

Description:

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.

Treatment:

Radiation: Only radiation therapy

Radiation therapy plus DC-CIK cellular therapy

Experimental group

Description:

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.

Treatment:

Other: Radiation therapy plus DC-CIK cellular therapy