Study of DC-CIK to Treat Colorectal Cancer

NCT01839539 | Unknown Phase 2 DMC

• 1 other identifier: CRC-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Colorectal Cancer

Keywords

colorectal cancer; DC-CIK; CRC

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  5 years

Secondary Outcomes (3)

• 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

Study Arms (2)

B

NO INTERVENTION

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

A

EXPERIMENTAL

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

Interventions

dendritic and cytokine-induced killer cells BIOLOGICAL

Also known as: DC-CIK

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangxi Medical University: lead

Study Sites (1)

Guangxi Medical University

Nanning, Guangxi, 530000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Hanfeng Liu

CONTACT

86-771-3277289

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: April 14, 2013
• First Posted: April 25, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 25, 2013

Record last verified: 2013-04

Locations

CN (1)