Study of DC-CIK to Treat Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01839539
• Other study ID #: CRC-01
• Status: Recruiting
• Phase: Phase 2
• First received: April 14, 2013
• Last updated: April 22, 2013
• Start date: March 2013
• Est. completion date: March 2018

Study information

• Verified date: April 2013
• Source: Guangxi Medical University
• Contact: Hanfeng Liu
• Phone: 86-771-3277289
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Biological:
• dendritic and cytokine-induced killer cells

Locations

Country	Name	City	State
China	Guangxi Medical University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		5 years	No
Secondary	Overall survival (OS)		5 years	No
Secondary	Quality of life (QOL)		5 years	No
Secondary	Laboratory findings (The number of CD3+ (or CD8+ or CD4+ or CD56+)T cell)		1 month	No