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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01691664
• Other study ID #: JR-02
• Status: Recruiting
• Phase: N/A
• Start date: September 2012
• Est. completion date: June 2022

Study information

• Verified date: October 2019
• Source: Capital Medical University
• Contact: Jun Ren, MD,PhD
• Phone: 86-10-63926317
• Email: renjun9688[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Radiation:
• Only radiation therapy
Patients only radiation therapy after surgery

Other:
• Radiation therapy plus DC-CIK cellular therapy
Patients receive radiation therapy plus DC-CIK cellular therapy after surgery

Locations

Country	Name	City	State
China	Beijing Shijitan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immunological assessment		Initial assessment, months 1,3,6and 12
Primary	Disease free survival		4 years
Secondary	quality of life		Initial assessment ? months 1,3,6 and 12