Study of DC-CIK to Treat Colorectal Cancer

NCT ID: NCT01839539

Last Updated: 2013-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2018-03-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

B

After neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy according to NCCN guidelines, patients will only regularly follow up.

Group Type: NO_INTERVENTION

No interventions assigned to this group

A

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).

Group Type: EXPERIMENTAL

dendritic and cytokine-induced killer cells

Intervention Type: BIOLOGICAL

Interventions

dendritic and cytokine-induced killer cells

Intervention Type: BIOLOGICAL

Other Intervention Names

DC-CIK

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Weiliang Sun

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangxi Medical University

Nanning, Guangxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hanfeng Liu

Role: CONTACT

86-771-3277289

Facility Contacts

Hanfeng Liu

Role: primary

86-771-3277289

Other Identifiers

CRC-01

Identifier Type: -

Identifier Source: org_study_id