A clinical study of autologous dendritic cells loaded with heat shock induced apoptotic tumor cells in the treatment of triple negative breast cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-15005955

Enrollment

Unknown

Registered

2015-02-03

Start date

2015-03-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

triple negative breast cancer

Interventions

two group:autologous dendritic cell vaccines

Eligibility

Sex/Gender

Female

Age

30 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. TNM staging II-IV stage and the diagnosis of patients with triple negative breast cancer by pathologic and immunohistochemical detection; 2. Married female infertility and to be aged 30 to 65 years; 3. KPS score more than at least 60 points, estimated survival of more than 6 months; 4. Adequate organ function, meeting the following criteria: absolute neutrophil count (ANC) more than 1.5*10^9/L, Platelet count more than at least 80*10^9/L, Hemoglobin more than at least 100g/L; ALT and AST less than at least 2.5 times the upper limit of normal, CCr more than at least 60ml/min or Cr less than at least 1.5 times the upper limit of normal; 5. No serious mental illness and no serious heart, liver, kidney, lung function is not complete, not combined with other deadly diseases; 6. Voluntary participation in the clinical trials and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients in pregnancy or breast-feeding period; 2. Serious or uncontrolled systemic disease or any instability of systemic disease (including but not limited to active infection, grade 3 hypertension, unstable angina pectoris, Congestive heart failure, grade III or IV cardiac disease, serious cardiac arrhythmias, liver and kidney function disorders or metabolic diseases), history of neurological or mental disorders, etc.; 3. Patients received organ transplantation; 4. Patients with history of autoimmune disease, for example SLE, rheumatic arthritis and angiitis; 5. Patients received other clinical trials in 3 months; 6. Unwilling to sign informed consent.

Design outcomes

Primary

Measure	Time frame
cytokine levels;tumor markers;PFS;DTH;CD8+IFN-gama+T%;	—

Secondary

Measure	Time frame
quality of life;lymphocyte subsets;	—

Countries

China

Contacts

Public ContactShi Hongzhen

shi_hongzhen@deconbio.com+86 025-58550158

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026