CIK in Treating Patients With Esophageal Cancer

Phase 2Not Yet RecruitingNCT02490735

The First People's Hospital of Changzhou2,000 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,000

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

CIK in Treating Patients With Esophageal Cancer

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes