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Clinical study of a dendritic cell vaccine combined with immune checkpoint inhibitors for treatment of glioblastoma

Clinical study of a dendritic cell vaccine combined with immune checkpoint inhibitors for treatment of glioblastoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025835
Enrollment
Unknown
Registered
2019-09-10
Start date
2019-10-01
Completion date
Unknown
Last updated
2019-09-16

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

Conditions

Glioblastoma

Interventions

Standard treatment combined with DC vaccine treatment group:Standard treatment combined with DC vaccine treatment
Standard treatment combined with DC vaccine and immune checkpoint blocker treatment group:Standard treatment combined with DC vaccine and immune checkpoint blocker treatment

Sponsors

Chinese People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Subjects must be willing and able to follow all aspects of the study protocol and to sign an informed consent form. 2. Patients must be diagnosed with supratentorial glioblastoma by histopathology (WHO grade IV). The maximum extent of resection must have been achieved during standard surgical treatment. The degree of resection must be demonstrated by surgery excision ranges >= 90% in postoperative MRI 3 days post-surgery. 3. Age between 18 and 65 years, male or female. 4. Symptoms associated with disease must remain clinically stable in the absence of another explanation. 5. Clinical laboratory test values must be within normal ranges. If abnormal results are obtained, the researcher must determine that these will have no relevant impact on the clinical research objectives. Blood and biochemical test indicator ranges: A. Liver damage: AST or ALT = 100 x 10^9/L; F. total neutrophils >= 1 x 10^9/L; G. anemia: hemoglobin >= 100 g/L. 6. KPS score >= 70 points, MMSE score >= 25 points, life expectancy >= 3 months.

Exclusion criteria

Exclusion criteria: 1. Women during pregnancy and lactation. 2. Patients who are allergic to the contrast agent, cell culture constituents or pharmaceutical reagents used in the study, or who have received other investigational drugs 30 days prior to the study. 3. Immunohistochemistry showing Ki67 >= 30%, or molecular pathology showing PTPRZ1-MET fusion gene mutation positive. 4. Previous history of systemic immune activators or inhibitors. 5. Active uncontrolled infections or comorbidities involving heart, liver, kidney, hematopoietic, blood, endocrine or other serious primary diseases. 6. Patients with T cell lymphoma or myeloma, autoimmune diseases, or who have undergone organ transplantation treated with immunosuppressive drugs. 7. Patients with severe disturbance of cognition, mental illness, dementia, or other patients who cannot cooperate. 8. Patients with a previous history of hepatitis (hepatitis B or hepatitis C), syphilis, or HIV/AIDS. 9. Patients with progressive disease, with MRI results judged to reflect pseudo-progressive or radioactive necrosis. 10. Patients judged to be unsuitable for the clinical trial.

Design outcomes

Primary

MeasureTime frame
MRI results;Progression free survival;Overall survival;Quality of life score;

Countries

China

Contacts

Public ContactTianyi Liu

Chinese People's Liberation Army General Hospital

ht514@126.com+86 13501238280

Outcome results

None listed

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