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This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of low-dose radiotherapy combined with programmed death 1 (PD-1) inhibitor (sintilimab) and temozolomide in recurrent glioblastoma. The eligible patients are scheduled to administered sintilimab 200mg D1 Q3W temozolomide 50mg/m2 QD and radiotherapy 1Gy/1F D1/D2/D8/D15 Q3W for 4-6 cycles, then sintilimab for maintenance. The overall primary study hypothesis is that the combination regimen of low-dose radiotherapy, sintilimab and temozolomide is safe and feasible in the treatment of recurrent glioblastoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose Radiotherapy Combined With Sintilimab and Temozolomide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | Sintilimab 200mg D1, Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival (PFS) | median progression free survival | from the first day of treatment to the follow up of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | median overall survival | from the first day of treatment to the follow up of 1 year |
| Adverse events | CTCAE 5.0 |
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Inclusion Criteria:
Histologically confirmed glioblastoma, radiographically or pathologically diagnosed recurrence.
Aged ≥ 18 years.
≥12 weeks after postoperative radiotherapy.
Karnofsky performance status (KPS) ≥ 60.
Expected survival > 3 months.
Adequate organ function, based on meeting all of the following criteria (no blood components and cytologic growth factors were received within 14 days prior to the test):
Subjects voluntarily join the study and sign an informed consent form, with good compliance.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingpeng Peng, Dr. | Contact | 07562526191 | pengyp3@outlook.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yingpeng Peng | Recruiting | Zhuhai | Guangdong | 519000 | China |
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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 |
|---|---|
| C000632826 | sintilimab |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Low-dose Radiotherapy | Radiation | Radiotherapy 1Gy/1F, D1/D2/D8/D15, Q3W |
|
| from the first day of treatment to the follow up of 1 year |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |