Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

• Status: Active, not recruiting
• Trial end date: 2033-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The prognosis of advanced breast cancer does not improve much recently although varies of adjuvant drugs have been tried.Dendritic cells co-cultured with cytokine-induced killer cells(DC-CIK) immunotherapy has been proved to improve survival in several cancers, but its role in advanced breast cancer stains unclear. The purpose of this study is to evaluate the efficacy and safety of DC-CIK immunotherapy combined with capecitabine versus capecitabine monotherapy for the treatment of advanced breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First People's Hospital of Changzhou
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• Histologically confirmed with advanced breast cancer.

• Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 2.

• Hemoglobin≥10.0g/dL, Neutrophil count≥1.5×10^9/L, Platelet count≥75×10^9/L; total bilirubin(TBIL)≤1.5×ULN; alkaline phosphatase(AKP), aspartate aminotransferase(AST),ALT≤2.5×ULN(without metastasis of the liver), AKP,AST,ALT≤5×ULN(with metastasis of the liver); BUN≤1.5×ULN, Cr≤1.5×ULN.

• Patient received 1-2 kinds of cytotoxic chemotherapy previously.

• Patient never received capecitabine or other oral fluorouracil.

Exclusion Criteria:

• Patients who are suffering from serious organ dysfunction.

• HIV positive or other immunodeficiency disease.

• Patients who had used long time or are using immunosuppressant drugs.

• Patients who had active infection.

• Patients who were allergic to fluorouracil.

• Pregnant or lactating women.

• History of other malignancies.

• Other situations that the researchers considered unsuitable for this study.