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NCT Number: NCT02490735

CIK in Treating Patients With Esophageal Cancer

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cytokine-Induced Killer Cells

Biological

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

Other names: CIK

Primary outcomes

  1. progression-free survival(PFS)

    Time frame: 1 month

Secondary outcomes

  1. overall survival(OS)

    Time frame: 1 month

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Changzhou

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2040
Study completion
2042
First posted
Jul 7, 2015
Registry last updated
Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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