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
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