A Phase 2 interventional study of DC-CIK and Radiotherapy in Colorectal Cancer, Neoplasms and Intestinal Neoplasms, sponsored by Shenzhen Hornetcorn Bio-technology Company, LTD. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-12-28.
Sponsored by Shenzhen Hornetcorn Bio-technology Company, LTD · Phase 2, Interventional, and Treatment
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).
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.
9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 7,250 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Shenzhen Hornetcorn Bio-technology Company, LTD is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will just regularly follow up.
Radiation: Radiotherapy · Drug: Chemotherapy
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 · Radiation: Radiotherapy · Drug: Chemotherapy
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.
45\~50 Gy in 25-28 fractions.
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.
Also known as: 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
The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell
Time frame: 1 year
This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Shenzhen Hornetcorn Bio-technology Company, LTD