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

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ClinicalTrials.gov Identifier: NCT02202928
Recruitment Status : Unknown
Verified July 2015 by Shenzhen Hornetcorn Bio-technology Company, LTD.
Recruitment status was:  Active, not recruiting
First Posted : July 29, 2014
Last Update Posted : December 28, 2015
Sponsor:
Collaborator:
Jingzhou Central Hospital
Information provided by (Responsible Party):
Shenzhen Hornetcorn Bio-technology Company, LTD

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Colorectal Cancer Neoplasms Intestinal Neoplasms Digestive System Neoplasms Gastrointestinal Diseases Biological: DC-CIK Radiation: Radiotherapy Drug: Chemotherapy Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Autologous Tumor Lysate-pulsed DC-CIK Cell in Colorectal Cancer After Surgery
Study Start Date : July 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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Arms and Interventions
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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 Name: 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.
 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.
Other Name: FOLFOX


Outcome Measures
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Primary Outcome Measures :
  1. Progress-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]
  2. Quality of life (QOL) [ Time Frame: 3 Years ]
  3. Phenotypic analysis of T cells [ Time Frame: 1 year ]
    The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202928


Locations
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China, Hubei
Jingzhou Central Hospital Immunotherapy center
Jingzhou, Hubei, China, 434020
Sponsors and Collaborators
Shenzhen Hornetcorn Bio-technology Company, LTD
Jingzhou Central Hospital
Investigators
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Principal Investigator: Ke N Zhang, Professor Jingzhou Central Hospital
More Information
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Responsible Party: Shenzhen Hornetcorn Bio-technology Company, LTD
ClinicalTrials.gov Identifier: NCT02202928    
Other Study ID Numbers: HYK-Colorectal Cancer
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: December 28, 2015
Last Verified: July 2015
Keywords provided by Shenzhen Hornetcorn Bio-technology Company, LTD:
Colorectal cancer
DC-CIK
Autologous tumor lysate
Additional relevant MeSH terms:
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Colorectal Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Intestinal Neoplasms
Gastrointestinal Diseases
Neoplasms
 Digestive System Diseases
Neoplasms by Site
Colonic Diseases
Intestinal Diseases
Rectal Diseases