Adoptive Cell Therapy Plus Chemotherapy and Radiation After Surgery in Treating Patients With Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Phase 2 Study of Autologous Tumor Lysate-pulsed DC-CIK Cell in Colorectal Cancer After Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02202928
• Other study ID #: HYK-Colorectal Cancer
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 25, 2014
• Last updated: December 23, 2015
• Start date: July 2014
• Est. completion date: December 2017

Study information

• Verified date: July 2015
• Source: Shenzhen Hornetcorn Bio-technology Company, LTD
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of autologous tumor lysate-pulsed dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC).

Description:

60 patients with stageⅠ~ Ⅲ CRC, who had received surgery and kept their tumor tissue, will be randomly divided into group A (receive DC-CIK treatment, chemotherapy and radiotherapy) or group B (just receive chemotherapy and radiotherapy), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of autologous tumor lysate pulsed DC-CIK cells treatment (every 4 weeks) and 4 cycles chemo-radiotherapy. Patients in group B will receive only 4 cycles chemo-radiotherapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18~80 years old;

• Histologically confirmed with colorectal cancer at stage ?~?;

• 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 - 1.

Exclusion Criteria:

• Hemoglobin<8.0 g/dL,Platelet count <75 x 10^9/L; ALT, AST, 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;

• History of organ allograft;

• Patients who had distant metastases;

• Patients who had active infection;

• Prior use of any anti-cancer treatment in 30 days;

• Now or recently will join another experimental clinical study ;

• Other situations that the researchers considered unsuitable for this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Digestive System Diseases
• Digestive System Neoplasms
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Intestinal Neoplasms
• Neoplasms

Intervention

Biological:
• DC-CIK
8×10^9 autologous tumor lysate pulsed DC-CIK cells for each infusion, IV (in the vein) for four cycles, each cycle received four infusions with a 1 day interval.

Radiation:
• Radiotherapy
45~50 Gy in 25-28 fractions.

Drug:
• Chemotherapy
Oxaliplatin 85mg/m2 IV over 2 hours, day 1; Leucovorin 400mg/m2 IV over 2 hours, day 1; 5-FU 400mg/m2 IV bolus on day 1, then 1200mg/m2/day for 2 days IV continuous infusion; Repeat every 2 weeks.

Locations

Country	Name	City	State
China	Jingzhou Central Hospital Immunotherapy center	Jingzhou	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen Hornetcorn Bio-technology Company, LTD	Jingzhou Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress-free survival		3 years	No
Secondary	Overall survival		3 years	No
Secondary	Quality of life (QOL)		3 Years	No
Secondary	Phenotypic analysis of T cells	The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell	1 year	No