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

C

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)

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

Trial contacts and locations

1

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Central trial contact

Jun Ren, MD,PhD

Data sourced from clinicaltrials.gov

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