Study of DC-CIK to Treat Colorectal Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC).

Detailed Description
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60 patients with stage Ⅲ CRC, who had received neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy according to NCCN guidelines, and got complete response (CR), will be randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of DC-CIK cells treatment (every 4 weeks). Patients in group B will have no anti-tumor therapy.

Official Title
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Phase Ⅱ Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Stage Ⅲ Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Biological: dendritic and cytokine-induced killer cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients ≥ 18 years of age; CRC with histological diagnose, and had received neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy and got complete response (CR) with imaging; Patients who have a life expectancy of at least 3 months; Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1; The bone marrow functioned normally (WBC > 4.0×109/L, Hb > 120 g/L, PLT > 100×109/L); The ECG results were normal, and the liver and kidney were functional. Exclusion Criteria: Patients who had distant metastases; Patients with uncontrolled infection; underlying disease that was severe or life-threatening; Patients who were pregnant or lactating; ECOG perform status ≥ 2; Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: B<br>After neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy according to NCCN guidelines, patients will only regularly follow up. | |
| Experimental: A<br>After neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy according to NCCN guidelines, patients will receive 2-3 cycles of Dendritic and Cytokine-induced Killer Cells (DC-CIK) treatment (every 4 weeks). | Biological: dendritic and cytokine-induced killer cells<br> <br> * Other names: DC-CIK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | 5 years | 
| Quality of life (QOL) |  | 5 years | 
| Laboratory findings (The number of CD3+ (or CD8+ or CD4+ or CD56+)T cell) |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, DC-CIK, CRC