CIK in Treating Patients With Esophageal Cancer

Soochow University

Status and phase

Not yet enrolling

Phase 2

Conditions

Esophageal Squamous Cell Carcinoma

Treatments

Biological: Cytokine-induced Killer Cells

Study type

Interventional

Funder types

Other

Identifiers

NCT02490735

ESCC-CZYY-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.