CIK in Treating Patients With Esophageal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cytokine-induced Killer Cells.
- Who it may be relevant to
- Registry conditions: Esophageal Squamous Cell Carcinoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Controlled Study of Cytokine-induced Killer Cells (CIK) Treatment in Patients With Staging Ⅰ-Ⅲ of Esophageal Carcinoma
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.
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.
Interventions
- Biological Cytokine-induced Killer Cells
chemotherapy plus 3 cycles of Cytokine-induced Killer Cells(CIK) treatment
Primary outcome measures
- progression-free survival(PFS) [Time frame: 1 month]
Secondary outcome measures (1)
- overall survival(OS) [Time frame: 1 month]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT02490735 · ESCC-CZYY-01