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

Not Applicable

Completed

• Conditions: Esophageal Carcinoma
• Interventions: Other: Concurrent chemoradiation only; Other: concurrent chemoradiotherapy plus DC-CIK immunotherapy

• Registration Number: NCT01691625
• Lead Sponsor: Capital Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-25
• Primary Completion: 2020-12
• Study Completion: 2021-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concurrent chemoradiation only	Concurrent chemoradiation only	patients will receive concurrent chemoradiotherapy only
concurrent chemoradiotherapy plus DC-CIK immunotherapy	concurrent chemoradiotherapy plus DC-CIK immunotherapy	patients will receive concurrent chemoradiotherapy plur DC-CIK immunotherapy

Primary Outcome Measures

Name	Time	Method
the quality of life	initial assessment, months 1, 3, 6 and 12

Secondary Outcome Measures

Name	Time	Method
progression-free survival	1 year

Trial Locations

Locations (1)

Capital Medical University Cancer Center; 🇨🇳 Beijing, Beijing, China