CIK in Treating Patients With Esophageal Cancer

July 2, 2015 updated by: The First People's Hospital of Changzhou

A Randomized Controlled Study of Cytokine-induced Killer Cells (CIK) Treatment in Patients With Staging Ⅰ-Ⅲ of Esophageal Carcinoma

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

About 2000 patients with staging I-III of Esophageal Cancer, after accepting chemotherapy, will be randomly divided into group A (receive CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK cells treatment (every 12 weeks). Patients in group B will have no anti-tumor therapy.

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No-CIK
After accepting chemotherapy, patients will regularly follow up.
Experimental: CIK
After accepting chemotherapy, patients will receive at least 3 cycles of Cytokine-induced Killer Cells treatment per year
Biological: Cytokine-induced Killer Cells
chemotherapy plus 3 cycles of Cytokine-induced Killer Cells(CIK) treatment
Other Names:
  • CIK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival(PFS)
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival(OS)
Time Frame: 1 month
1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage at diagnosis
Time Frame: 1 month
Tumor Node Metastasis (TNM) stage, Tumor:CIS,T1,T2,T3,T4 according to the depth of tumor invasion. Lymph node involvement: N0,N1,N2. Metastasis: M0,M1
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First People's Hospital of Changzhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

August 1, 2040

Study Completion (Anticipated)

August 1, 2042

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimate)

July 7, 2015

Study Record Updates

Last Update Posted (Estimate)

July 7, 2015

Last Update Submitted That Met QC Criteria

July 2, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESCC-CZYY-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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