Study of DC-CIK to Treat Colorectal Cancer

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01839539

Enrollment

Registered

2013-04-25

Start date

2013-03-31

Completion date

2018-03-31

Last updated

2013-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

colorectal cancer, DC-CIK, CRC

Brief summary

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

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.

Interventions

BIOLOGICALdendritic and cytokine-induced killer cells

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male or female patients ≥ 18 years of age; 2. CRC with histological diagnose, and had received neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy and got complete response (CR) with imaging; 3. Patients who have a life expectancy of at least 3 months; 4. Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1; 5. The bone marrow functioned normally (WBC \> 4.0×109/L, Hb \> 120 g/L, PLT \> 100×109/L); 6. The ECG results were normal, and the liver and kidney were functional.

Exclusion criteria

1. Patients who had distant metastases; 2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening; 3. Patients who were pregnant or lactating; 4. ECOG perform status ≥ 2; 5. Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS)	5 years

Secondary

Measure	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

Countries

China

Contacts

Primary ContactHanfeng Liu

86-771-3277289

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026