Status:
UNKNOWN
Neoadjuvant PD-1 Antibody Alone or Combined With DC Vaccines for Recurrent Glioblastoma
Lead Sponsor:
Huashan Hospital
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Shanghai Sunstem Biotechnology Co., Ltd.
Conditions:
Recurrent Glioblastoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Glioblastoma multiforme (GBM) are the most prevalent malignant tumor in central nervous system. At recurrence, no clear standard-of-care therapy is agreed for recurrent GBM (rGBM) and median overall s...
Detailed Description
This is a phase II randomized controlled clinical study. The purpose of this research is to study the safety and efficacy of Camrelizumab alone or combined with GSC-DCV vaccines in treating patients w...
Eligibility Criteria
Inclusion
- Age from 18 to 70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
- Estimated life expectancy \> 3 months.
- Previous first-line therapy with radiotherapy and chemotherapy, first or second relapse with unequivocal evidence of tumor progression.
- Pathological diagnosis or molecular diagnosis for lesion this time was confirmed to be recurrent brain glioma (WHO grade 4).
- Patients with subtotal resection or above of the tumor confirmed with contrast MR within 72 hours after surgery.
- No high-dose systemic corticosteroids (defined as \>10 mg day-1 of prednisone or bio-equivalent for at least seven consecutive days before administration).
- No antibiotics for at least three consecutive days before administration.
- Adequate organ function defined by:
- Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥ 1.0×10\^9/L, platelets ≥100×10\^9/L; hemoglobin ≥ 8 g/dL. Hepatic: bilirubin 2×upper limit of normal (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) \< 2.5×upper limit of normal (ULN). Renal: Normal serum Creatinine for age (below) or creatinine clearance \>60 ml/min/1.73 m2. Electrocardiogram: normal.
- Written informed consent.
- Patient should have good follow-up compliance.
Exclusion
- Pregnant or breast-feeding patients.
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with history of immune system abnormalities such as hyperimmunity (e.g., autoimmune diseases) and hypoimmunity (e.g., myelodysplastic disorders, marrow failures, AIDS, ongoing pregnancy, transplant immuno-suppression), or medication of cortisol.
- Patients with any conditions that could potentially alter immune function (e.g., AIDS, multiple sclerosis, diabetes, renal failure).
- Any previous investigational medication within 30 days before first administration of Camrelizumab.
- History of allergy to study drug components or of severe hypersensitivity reactions to any monoclonal antibodies.
Key Trial Info
Start Date :
October 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04888611
Start Date
October 26 2021
End Date
May 1 2024
Last Update
November 30 2021
Active Locations (1)
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1
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040