CIK in Treating Patients With Esophageal Cancer

NCT02490735 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: ESCC-CZYY-01
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chemotherapy is the main treatment method for patients with Esophageal Cancer. However, Relapse remains the major cause of treatment failure.Biological therapies such as CIK stimulate the immune system and stop tumor cells from growing. A series of studies reported that cytokine-induced killer cells (CIK) have a broad anti-tumor spectrum. The investigators suppose that CIK will improve the prognosis. Combining chemotherapy with biological therapy may kill more tumor cells. In this study, the patients will be treated with CIK cells after chemotherapy. The purpose of this study is to evaluate the efficacy of CIK for Esophageal Cancer.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• progression-free survival(PFS)

  1 month

Secondary Outcomes (1)

• overall survival(OS)

  1 month

Other Outcomes (1)

• Stage at diagnosis

  1 month

Study Arms (2)

No-CIK

NO INTERVENTION

After accepting chemotherapy, patients will regularly follow up.

CIK

EXPERIMENTAL

After accepting chemotherapy, patients will receive at least 3 cycles of Cytokine-induced Killer Cells treatment per year

Biological: Cytokine-induced Killer Cells

Interventions

Cytokine-induced Killer Cells BIOLOGICAL

chemotherapy plus 3 cycles of Cytokine-induced Killer Cells(CIK) treatment

Also known as: CIK

CIK

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients histologically confirmed esophageal carcinoma;
• Patients with staging I-III of esophageal carcinoma;
• Patients who had completed chemotherapy;
• Patients who have a life expectancy of at least 12 weeks;
• Eastern Cooperative Oncology Group (ECOG) performance status was 0-1;
• The bone marrow functioned normally (WBC\>4.0×10\^9/L, Hb\>120 g/L, Platelet(PLT)\>100×10\^9/L);
• The ECG results were normal, and the liver and kidney were functional.

You may not qualify if:

• Patients who had distant metastases by imaging studies;
• Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
• Patients who were lactating;
• ECOG perform status ≥ 2;
• Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment;
• Patients who are pregnant or nursing;
• Patients with active tuberculosis (highly positive skin tests allowed if no active disease);
• Patients with disease that would preclude general anesthesia;
• Patients with active intractable or uncontrollable infection.

Sponsors & Collaborators

• The First People's Hospital of Changzhou: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 7, 2015
• Study Start: August 1, 2015
• Primary Completion (Estimated): August 1, 2040
• Study Completion (Estimated): August 1, 2042
• Last Updated: July 7, 2015

Record last verified: 2015-07