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

Arm | Intervention/treatment |
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Sham Comparator: Chemo-radiotherapy
After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will just regularly follow up.
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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.
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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 |
- Progress-free survival [ Time Frame: 3 years ]
- Overall survival [ Time Frame: 3 years ]
- Quality of life (QOL) [ Time Frame: 3 Years ]
- Phenotypic analysis of T cells [ Time Frame: 1 year ]The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell

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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 |
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.

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
China, Hubei | |
Jingzhou Central Hospital Immunotherapy center | |
Jingzhou, Hubei, China, 434020 |
Principal Investigator: | Ke N Zhang, Professor | Jingzhou Central Hospital |
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 |
Colorectal cancer DC-CIK Autologous tumor lysate |
Neoplasms Colorectal Neoplasms Digestive System Neoplasms Gastrointestinal Neoplasms Intestinal Neoplasms Gastrointestinal Diseases |
Digestive System Diseases Neoplasms by Site Colonic Diseases Intestinal Diseases Rectal Diseases |