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

Primary Purpose

Colorectal Cancer, Neoplasms, Intestinal Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
DC-CIK
Radiotherapy
Chemotherapy
Sponsored by
Shenzhen Hornetcorn Bio-technology Company, LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal cancer, DC-CIK, Autologous tumor lysate

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jingzhou Central Hospital Immunotherapy center

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Chemo-radiotherapy

DC-CIK

Arm Description

After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will just regularly follow up.

After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will receive 3 cycles of autologous tumor lysate pulsed DC-CIK treatment.

Outcomes

Primary Outcome Measures

Progress-free survival

Secondary Outcome Measures

Overall survival
Quality of life (QOL)
Phenotypic analysis of T cells
The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell

Full Information

First Posted
July 25, 2014
Last Updated
December 23, 2015
Sponsor
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators
Jingzhou Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02202928
Brief Title
Adoptive Cell Therapy Plus Chemotherapy and Radiation After Surgery in Treating Patients With Colorectal Cancer
Official Title
Phase 2 Study of Autologous Tumor Lysate-pulsed DC-CIK Cell in Colorectal Cancer After Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators
Jingzhou Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Neoplasms, Intestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases
Keywords
Colorectal cancer, DC-CIK, Autologous tumor lysate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemo-radiotherapy
Arm Type
Sham Comparator
Arm Description
After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will just regularly follow up.
Arm Title
DC-CIK
Arm Type
Experimental
Arm Description
After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will receive 3 cycles of autologous tumor lysate pulsed DC-CIK treatment.
Intervention Type
Biological
Intervention Name(s)
DC-CIK
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
45~50 Gy in 25-28 fractions.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
FOLFOX
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progress-free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
3 years
Title
Quality of life (QOL)
Time Frame
3 Years
Title
Phenotypic analysis of T cells
Description
The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ke N Zhang, Professor
Organizational Affiliation
Jingzhou Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jingzhou Central Hospital Immunotherapy center
City
Jingzhou
State/Province
Hubei
ZIP/Postal Code
434020
Country
China

12. IPD Sharing Statement

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

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