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

NCT01691625 | Completed

• 1 other identifier: JR-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Carcinoma

Keywords

Locally advanced esophageal carcinoma; DC-CIK; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• the quality of life

  initial assessment, months 1, 3, 6 and 12

Secondary Outcomes (1)

• progression-free survival

  1 year

Other Outcomes (1)

• Immunological assessment

  baseline, months 1, 3, 6 and 12

Study Arms (2)

concurrent chemoradiotherapy plus DC-CIK immunotherapy

EXPERIMENTAL

patients will receive concurrent chemoradiotherapy plur DC-CIK immunotherapy

Other: concurrent chemoradiotherapy plus DC-CIK immunotherapy

Concurrent chemoradiation only

ACTIVE COMPARATOR

patients will receive concurrent chemoradiotherapy only

Other: Concurrent chemoradiation only

Interventions

concurrent chemoradiotherapy plus DC-CIK immunotherapy OTHER

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 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator. Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation. DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition apheresis 3 days before concurrent chemoradiation, and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times between the Chemoradiation intermittent period.

concurrent chemoradiotherapy plus DC-CIK immunotherapy

Concurrent chemoradiation only OTHER

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 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator. Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation.

Concurrent chemoradiation only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Capital Medical University Cancer Center

Beijing, Beijing Municipality, 100038, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,Capital Medical University (CMU)Cancer Center,

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 25, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

CN (1)