DC-CIK Immunotherapy Plus Chemotherapy vs Chemotherapy Alone in the Adjuvant Treatment of Stage III Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Randomized Controlled Trial Comparing DC-CIK Immunotherapy Combined With Adjuvant Chemotherapy and Adjuvant Chemotherapy Alone in Stage III Colorectal Cancer.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02415699
• Other study ID #: 2015045010
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: April 9, 2015
• Last updated: April 13, 2015
• Start date: August 2015
• Est. completion date: July 2020

Study information

• Verified date: April 2015
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Xiaojian Wu, MD, PHD
• Phone: 020-38254009
• Email: sumswxj[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethic Committee, Sun Yat-sen University
• Study type: Interventional

Clinical Trial Summary

Stage III colorectal cancer constitutes more than half of the colorectal patients, and the prognosis does not improve much recently although varies of adjuvant drugs have been tried. DC-CIK immunotherapy has been proved to improve survival in cancer patients, but its role in stage III colorectal cancer patients stains unclear. The investigators study will focus on the efficacy and safety of DC-CIK immunotherapy plus chemotherapy in the adjuvant treatment of stage III colorectal cancer, compared with chemotherapy alone.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2020
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Stage III colon cancer

• Undergone complete resection of primary tumor

• Completed standard adjuvant chemotherapy

• ECOG performancer status 0-2

• Adequate hematologic, hepatic and renal functions

Exclusion Criteria:

• HIV positive or other Immunodeficiency disease

• Uncontrolled hypertension

• History of recent cancers in the past 5 years

• Patients with previous or concurrent malignancy or any anti-cancer therapy

• Patients who were allergic to platinum drugs or fluorouracil

• Pregnant patients

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Fluorouracil

• Oxaliplatin

• Leucovorin

Biological:
• DC-CIK

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		2 years	Yes
Secondary	Overall survival		2 years	Yes
Secondary	Side Effect		6 month	Yes