The Efficacy and Safety of Low-dose Radiotherapy Combined With Sintilimab and Temozolomide in Recurrent Glioblastoma
Recruiting
Phase 2
Interventional Study
Recurrent Glioblastoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University · Other
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About This Trial
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 f…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Histologically confirmed glioblastoma, radiographically or pathologically diagnosed recurrence.
2. Aged ≥ 18 years.
3. ≥12 weeks after postoperative radiotherapy.
4. Karnofsky performance status (KPS) ≥ 60.
5. Expected survival \> 3 months.
6. Adequate organ function, based o…
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