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

Sun Yat-sen University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Colorectal Cancer

Treatments: Biological: DC-CIK; Drug: Oxaliplatin; Drug: Fluorouracil; Drug: Leucovorin

Study type: Interventional

Funder types: Other

Identifiers

NCT02415699

2015045010

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

DC-CIK Immunotherapy Plus Chemotherapy

Experimental group

Description:

Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group

Treatment:

Drug: Leucovorin

Biological: DC-CIK

Drug: Fluorouracil

Drug: Oxaliplatin

Chemotherapy Alone

Active Comparator group

Description:

Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone.

Treatment:

Drug: Leucovorin

Drug: Fluorouracil

Drug: Oxaliplatin