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

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

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).

Study Overview

• Status: Unknown
• Conditions: Gastrointestinal Diseases; Neoplasms; Digestive System Neoplasms; Intestinal Neoplasms; Colorectal Cancer
• Intervention / Treatment: Radiation: Radiotherapy; Drug: Chemotherapy; Biological: DC-CIK

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hubei
    • Jingzhou, Hubei, China, 434020
      • Jingzhou Central Hospital Immunotherapy center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18~80 years old;
• Histologically confirmed with colorectal cancer at stage Ⅰ~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 - 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Chemo-radiotherapy; After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will just regularly follow up.	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.; Other Names: FOLFOX
Experimental: DC-CIK; After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will receive 3 cycles of autologous tumor lysate pulsed DC-CIK treatment.	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.; Other Names: FOLFOX; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progress-free survival	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		3 years
Phenotypic analysis of T cells	The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell	1 year
Quality of life (QOL)		3 Years

Collaborators and Investigators

• Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD
• Collaborators: Jingzhou Central Hospital
• Investigators: Principal Investigator: Ke N Zhang, Professor, Jingzhou Central Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: July 25, 2014
• First Submitted That Met QC Criteria: July 25, 2014
• First Posted (Estimate): July 29, 2014

Study Record Updates

• Last Update Posted (Estimate): December 28, 2015
• Last Update Submitted That Met QC Criteria: December 23, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Colorectal cancer; DC-CIK; Autologous tumor lysate
• Additional Relevant MeSH Terms: Neoplasms by Site; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms; Colorectal Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Intestinal Neoplasms
• Other Study ID Numbers: HYK-Colorectal Cancer