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Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer

Information source: Capital Medical University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Esophageal Carcinoma

Intervention: concurrent chemoradiotherapy plus DC-CIK immunotherapy (Other); Concurrent chemoradiation only (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Capital Medical University

Overall contact:
Jun Ren, MD, PhD, Phone: 86-10-63926317, Email: renjun9688@yahoo.com

Summary

The purpose of this study is to show if the adoptive cellular therapy with autologous dendritic cells and cytokine-induced killer cells (CIK) combined with concurrent chemoradiation could improve the quality of life of the patients with locally advanced esophageal cancer, compared with concurrent chemoradiation only.

Clinical Details

Official title: Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: the quality of life

Secondary outcome: progression-free survival

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- cytologically or histologically confirmed locally advanced esophageal carcinoma

- Age: > 18

- Karnofsky performance status ≥ 70

- At least one measurable tumor lesions according to the RECIST criteria.

- 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

- Informed consent signed

Exclusion Criteria:

- Patients with metastatic disease in the central nervous system (CNS).

- Patients who are pregnant or nursing.

- Patients with poor bone marrow, liver and kidney functions, which would make

chemotherapy intolerable

- Patients with contraindication for irradiation: complete obstruction of esophagus,

deep esophageal ulcer, fistula to mediastinum, or haematemesis

- coexisted morbidities that investigators believed not suitable for chemoradiation

Locations and Contacts

Jun Ren, MD, PhD, Phone: 86-10-63926317, Email: renjun9688@yahoo.com

Capital Medical University Cancer Center, Beijing, Beijing 100038, China; Recruiting
Jun Ren, MD, PhD, Phone: 86-10-63926317, Email: renjun9688@yahoo.com
Jun Ren, MD, PhD, Principal Investigator
Additional Information

Starting date: September 2012
Last updated: January 27, 2015

Page last updated: August 20, 2015

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