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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil; Biological: DC-CIK

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DC-CIK Immunotherapy Plus Chemotherapy; Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group	Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil; Other Names: 5-FU; Biological: DC-CIK
Active Comparator: Chemotherapy Alone; Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone.	Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil; Other Names: 5-FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease free survival	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	2 years
Side Effect	6 month

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: April 9, 2015
• First Submitted That Met QC Criteria: April 13, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 13, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Fluorouracil; Oxaliplatin; Leucovorin
• Other Study ID Numbers: 2015045010