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

Sixth Affiliated Hospital, Sun Yat-sen University100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Colorectal Cancer

Interventions

Fluorouracil

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Disease free survival

Time frame: 2 years

Secondary Outcomes

Overall survival