Adoptive Cell Therapy Plus Chemotherapy and Radiation After Surgery in Treating Patients With Colorectal Cancer
NCT02202928 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2015-12-28
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).
Conditions
- Colorectal Cancer
- Neoplasms
- Intestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
Interventions
- 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
-
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.
Sponsors & Collaborators
-
Jingzhou Central Hospital
collaborator OTHER -
Shenzhen Hornetcorn Bio-technology Company, LTD
lead INDUSTRY
Principal Investigators
-
Ke N Zhang, Professor · Jingzhou Central Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-31
- Primary Completion
- 2017-12-31
- Completion
- 2017-12-31
Countries
- China
Study Locations
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