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

Not Applicable

• Conditions: Esophageal Cancer
• Interventions: Radiation: Only radiation therapy; Other: Radiation therapy plus DC-CIK cellular therapy

• Registration Number: NCT01691664
• Lead Sponsor: Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-18
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-25
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-04
• Primary Completion: 2021-12
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Only radiation therapy	Only radiation therapy	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.
Radiation therapy plus DC-CIK cellular therapy	Radiation therapy plus DC-CIK cellular therapy	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.

Primary Outcome Measures

Name	Time	Method
Disease free survival	4 years

Secondary Outcome Measures

Name	Time	Method
quality of life	Initial assessment → months 1,3,6 and 12

Trial Locations

Locations (1)

Beijing Shijitan Hospital; 🇨🇳 Beijing, Beijing, China