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This is a randomized, double-blind, controlled and multi-center Phase III clinical trial to evaluate the safety and efficacy of ASC40 tablets combined with bevacizumab in the treatment of adult patients with recurrent glioblastoma. After standard radiotherapy and chemotherapy (temozolomide), the subject first experienced clinical recurrence or progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASC40 | Experimental | ASC40 tablets 100mg/m^2 and bevacizumab 10mg/kg. |
|
| Placebo | Placebo Comparator | Placebo and bevacizumab 10mg/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC40 tablets | Drug | ASC40 tablets administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | The time of progression or death from any cause in randomly grouped diseases (whichever comes first) was compared with the control group (evaluated by Independent Imaging Evaluation Committee [IRC]) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months |
| Total survival | the time from random grouping to death, compared with the control group. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective remission rate | It is evaluated once in the 4th week after using experimental drugs (experimental drug group or control group), and then every 8 weeks until the disease progresses or dies (evaluated by [IRC]). | Week 4 to Month 6 (every 8 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital,Capital Medical University | Beijing | Beijing Municipality | 100071 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40404984 | Derived | Dembitz V, James SC, Gallipoli P. Targeting lipid metabolism in acute myeloid leukemia: biological insights and therapeutic opportunities. Leukemia. 2025 Aug;39(8):1814-1823. doi: 10.1038/s41375-025-02645-z. Epub 2025 May 22. |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| C000717092 | TVB-2640 |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Placebo tablets | Drug | Placebo administered orally once daily. |
|
| Bevacizumab | Drug | Bevacizumab once every 2 weeks, intravenous drip. |
|
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |