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

Phase 2

• Conditions: Colorectal Cancer
• Interventions: Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin; Biological: DC-CIK

• Registration Number: NCT02415699
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-04
• Study First Submitted: 2015-04-09
• Study First Submitted QC: 2015-04-13
• Last Update Submitted: 2015-04-13
• Study First Posted: 2015-04-14
• Last Update Posted: 2015-04-14
• Study Start: 2015-08
• Primary Completion: 2017-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DC-CIK Immunotherapy Plus Chemotherapy	DC-CIK	Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group
DC-CIK Immunotherapy Plus Chemotherapy	Fluorouracil	Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group
DC-CIK Immunotherapy Plus Chemotherapy	Oxaliplatin	Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group
DC-CIK Immunotherapy Plus Chemotherapy	Leucovorin	Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group
Chemotherapy Alone	Fluorouracil	Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone.
Chemotherapy Alone	Oxaliplatin	Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone.
Chemotherapy Alone	Leucovorin	Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone.

Primary Outcome Measures

Name	Time	Method
Disease free survival	2 years

Secondary Outcome Measures

Name	Time	Method
Side Effect	6 month
Overall survival	2 years