Study of DC-CIK to Treat Colorectal Cancer

Phase 2

• Conditions: Colorectal Cancer
• Interventions: Biological: dendritic and cytokine-induced killer cells

• Registration Number: NCT01839539
• Lead Sponsor: Guangxi Medical University

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.

Study Timeline

• Study Start: 2013-03
• Status Verified: 2013-04
• Study First Submitted: 2013-04-14
• Study First Submitted QC: 2013-04-22
• Last Update Submitted: 2013-04-22
• Study First Posted: 2013-04-25
• Last Update Posted: 2013-04-25
• Primary Completion: 2018-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	dendritic and cytokine-induced killer cells	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).

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	5 years

Secondary Outcome Measures

Name	Time	Method
Laboratory findings (The number of CD3+ (or CD8+ or CD4+ or CD56+)T cell)	1 month
Overall survival (OS)	5 years
Quality of life (QOL)	5 years

Trial Locations

Locations (1)

Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China