NCT04888611

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

Status unknown Phase 2 Last updated 30 November 2021

What this trial tests

Phase 2 trial testing Camrelizumab plus GSC-DCV in Recurrent Glioblastoma in 40 participants. Status unknown.

Timeline

26 October 2021

Primary endpoint
1 May 2023

1 May 2024

Quick facts

Lead sponsor	Huashan Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	26 October 2021
Primary completion	1 May 2023
Estimated completion	1 May 2024
Sites	1 location across China

Drugs / interventions tested

• Camrelizumab plus GSC-DCV — full drug profile →
• Camrelizumab plus Placebo — full drug profile →

Conditions studied

• Recurrent Glioblastoma — all drugs for Recurrent Glioblastoma →

Sponsor

Huashan Hospital

Who can join

Adults 18 to 70, any sex, with Recurrent Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cancer stem cells: advances in knowledge and implications for cancer therapy.
   Chu X, Tian W, Ning J, Xiao G, et al · · 2024 · cited 311× · PMID 38965243 · DOI 10.1038/s41392-024-01851-y
2. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
   Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
3. Trial watch: Dendritic cell (DC)-based immunotherapy for cancer.
   Laureano RS, Sprooten J, Vanmeerbeerk I, Borras DM, et al · · 2022 · cited 101× · PMID 35800158 · DOI 10.1080/2162402x.2022.2096363
4. Impaired function of dendritic cells within the tumor microenvironment.
   Xiao Z, Wang R, Wang X, Yang H, et al · · 2023 · cited 61× · PMID 37441069 · DOI 10.3389/fimmu.2023.1213629
5. Glioblastoma vaccines: past, present, and opportunities.
   Xiong Z, Raphael I, Olin M, Okada H, et al · · 2024 · cited 57× · PMID 38183840 · DOI 10.1016/j.ebiom.2023.104963
6. Translational landscape of glioblastoma immunotherapy for physicians: guiding clinical practice with basic scientific evidence.
   Kreatsoulas D, Bolyard C, Wu BX, Cam H, et al · · 2022 · cited 53× · PMID 35690784 · DOI 10.1186/s13045-022-01298-0
7. Circulating Liquid Biopsy Biomarkers in Glioblastoma: Advances and Challenges.
   Seyhan AA. · · 2024 · cited 44× · PMID 39063215 · DOI 10.3390/ijms25147974
8. Early Therapeutic Interventions for Newly Diagnosed Glioblastoma: Rationale and Review of the Literature.
   Waqar M, Trifiletti DM, McBain C, O'Connor J, et al · · 2022 · cited 27× · PMID 35119629 · DOI 10.1007/s11912-021-01157-0