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NCT02491697Active, not recruitingPhase 2

Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

Randomized Controlled Trial Comparing Dendritic Cells Co-cultured With Cytokine-induced Killer Cells Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

Source: ClinicalTrials.gov · Last updated 23 Feb 2016

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
400 (estimated)
First submitted
1 Jul 2015
Start date
Feb 2016
Primary completion date
Aug 2030
Lead sponsor
The First People's Hospital of Changzhou
NCT number
NCT02491697

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 400
  • From Feb 2016 to the primary completion date, Aug 2030
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • HIV positive or other immunodeficiency disease.
  • Patients who had active infection.
  • Patients who were allergic to fluorouracil.
  • History of other malignancies.

Other

  • Patients who are suffering from serious organ dysfunction.
  • Pregnant or lactating women.
  • Other situations that the researchers considered unsuitable for this study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.