Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jingzhou Central Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 stageâ… ~ â…¢ 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemo-radiotherapy | Sham Comparator | After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will just regularly follow up. |
|
| DC-CIK | Experimental | After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will receive 3 cycles of autologous tumor lysate pulsed DC-CIK treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC-CIK | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 3 years | |
| Quality of life (QOL) | 3 Years | |
| Phenotypic analysis of T cells |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ke N Zhang, Professor | Jingzhou Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jingzhou Central Hospital Immunotherapy center | Jingzhou | Hubei | 434020 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Radiotherapy | Radiation | 45~50 Gy in 25-28 fractions. |
|
| Chemotherapy | 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. |
|
|
The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell
| 1 year |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| D007414 | Intestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D004358 | Drug Therapy |
| C410216 | Folfox protocol |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided