Autologous Tumor Tissue Antigen-sensitized DC-CIK Cells Combined With Chemotherapy for Esophageal Cancer

Shenzhen Hornetcorn Biotechnology

Status and phase: Unknown; Phase 2

Conditions: Esophageal Cancer; Neoplasms; Digestive System Neoplasms; Esophageal Neoplasms

Treatments: Biological: DC-CIK; Drug: Cisplatin; Drug: Paclitaxel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02644863

HYK-esophageal cancer

Details and patient eligibility

About

This study evaluates the safety and efficacy of D-CIK immune cells combined with chemotherapy after resection of esophageal cancer

Full description

60 patients of esophageal cancer with TNM stage of tumor stage II-III,who had received surgery and kept their tumor tissue, will be randomly divided into group A (receive cancer tissue antigen sensitized D-CIK immune cells in combination with chemotherapy treatment) or group B (just receive chemotherapy), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of autologous antigen-sensitized DC-CIK cells treatment (every 4 weeks) and chemotherapy. Patients in group B will receive only 3 cycles chemotherapy.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-75 years old;
• Clinical diagnosis of esophageal cancer patients,tumor TNM stageII-III;
• Patients who can accept curative operations;
• Patients who have a life expectancy of at least 3 months; .Eastern Cooperative Oncology Group (ECOG) performance status was 0-2.

Exclusion criteria

• White blood cell <3 x 10^9/L,Platelet count <75 x 10^9/L;BUN and Cr more than normal limits on 3.0 times ;
• Known or suspected allergy to the investigational agent or any agent given in association with this trial;
• Pregnant or lactating patients;
• Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
• Patients who are suffering from serious autoimmune disease;
• Patients who had used long time or are using immunosuppressant;
• Patients who had active infection;
• Prior use of any anti-cancer treatment in 30 days;
• Now or recently will join another experimental clinical study ;
• History of organ allograft;
• Other situations that the researchers considered unsuitable for this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

DC-CIK

Experimental group

Description:

After accepting chemotherapy according to guidelines,patients will receive 3 cycles of autologous DC-CIK treatment.

Treatment:

Drug: Paclitaxel

Biological: DC-CIK

Drug: Cisplatin

Chemotherapy

Sham Comparator group

Description:

After the Chemotherapy by Paclitaxel and Cisplatin, patients will just regularly follow up.

Treatment:

Drug: Paclitaxel

Drug: Cisplatin