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Glioblastoma

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Glioma

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Neuroectodermal Tumors, Primitive

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Neoplasms, Glandular and Epithelial

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All Drugs and Chemicals

Antibodies

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Immunoglobulins

Patients will receive neoadjuvant Camrelizumab (PD-1 antibody), followed by surgical resection, DC vaccines and further PD-1 inhibitor treatment until toxicity or progression.

Patients will receive neoadjuvant Camrelizumab (PD-1 antibody), followed by surgical resection, placebo and further PD-1 inhibitor treatment until toxicity or progression.

Prior to scheduled surgery, patients need to receive Camrelizumab IV (3mg/kg, up to 200mg). After surgery, patients receive Camrelizumab IV (3mg/kg, up to 200mg) and GSC-DCV IH every 3 weeks in the absence of disease progression or unacceptable toxicity.

Camrelizumab plus GSC-DCV

Prior to scheduled surgery, patients need to receive Camrelizumab IV (3mg/kg, up to 200mg). After surgery, patients receive Camrelizumab IV (3mg/kg, up to 200mg) and Placebo IH every 3 weeks in the absence of disease progression or unacceptable toxicity.

Camrelizumab plus Placebo

Yu Yao, MD

Liangfu Zhou, MD

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 survival is estimated to rarely exceed 6-9 months with effective therapies. Neoadjuvant therapy with anti-PD-1 monoclonal antibodies were confirmed to be helpful to extend survival in rGBM. Vaccine, dendritic cells (DCs) pulsed with glioblastoma stem-like cell (GSC) antigens (GSC-DCV), could extend survival for GBM patients in our previous clinical study (PMID: 30159779). The purpose of this study is to evaluate the safety and efficiency of using the neoadjuvant therapy with PD-1 antibody (Carilizumab) plus DC vaccine (GSC-DCV) in patients with recurrent glioblastoma.

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 with recurrent glioblastomas. The participants will be randomly assigned into two group. Patients in group A will receive neoadjuvant Camrelizumab (PD-1 antibody), followed by surgical resection, DC vaccines and further PD-1 inhibitor treatment until toxicity or progression. Patients in group B will receive neoadjuvant Camrelizumab (PD-1 antibody), followed by surgical resection, placebo and further PD-1 inhibitor treatment until toxicity or progression. Furthermore, to evaluate the associations between exploratory biomarkers, clinical outcomes, and adverse events based on the next generation sequencing.

Neoadjuvant PD-1 Antibody Alone or Combined With DC Vaccines for Recurrent Glioblastoma

Neoadjuvant PD-1 Antibody Alone or Combined With Autologous Glioblastoma Stem-like Cell Antigens-primed DC Vaccines (GSC-DCV) for Patients With Recurrent Glioblastoma：A Phase II, Randomized Controlled, Double Blind Clinical Trial.

To investigate the association between biomarkers and clinical outcomes using diverse biospecimen based on the next generation sequencing, including ctDNA, TIL (tumor infiltrating lymphocyte) density and TCR (T cell receptor) Clonality, gene expression signature, genomic mutation, microbial bacteria and so on.

Time from enrollment to the dates of death from any cause or last follow up reported

Time from enrollment to the dates of disease progression, death from any cause or last tumor assessment reported between date of first patient enrollment

Toxicity assessed by Common Terminology Criteria for Adverse Events

Response rate assessed by immunotherapy Response Assessment for Neuro-Oncology (iRANO) criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant PD-1 Antibody Alone or Combined With DC Vaccines for Recurrent Glioblastoma	NCT04888611	Recurrent Gliob...	Camrelizumab pl... Camrelizumab pl...	18 Years - 70 Years	Huashan Hospital
Neoadjuvant PD-1 Antibody Alone or Combined With DC Vaccines for Recurrent Glioblastoma	NCT04888611	Recurrent Gliob...	Camrelizumab pl... Camrelizumab pl...	18 Years - 70 Years	Huashan Hospital

Spots Global Cancer Trial Database for camrelizumab plus placebo