Randomized Controlled Trial Comparing DC-CIK Immunotherapy Combined With Adjuvant Chemotherapy and Adjuvant Chemotherapy Alone in Stage III Colorectal Cancer.
Overview
- Phase
- Phase 2
- Intervention
- Fluorouracil
- Conditions
- Colorectal Cancer
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Enrollment
- 100
- Primary Endpoint
- Disease free survival
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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
Intervention: Fluorouracil
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
Intervention: Oxaliplatin
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
Intervention: Leucovorin
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
Intervention: DC-CIK
Chemotherapy Alone
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone.
Intervention: Fluorouracil
Chemotherapy Alone
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone.
Intervention: Oxaliplatin
Chemotherapy Alone
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone.
Intervention: Leucovorin
Outcomes
Primary Outcomes
Disease free survival
Time Frame: 2 years
Secondary Outcomes
- Side Effect(6 month)
- Overall survival(2 years)