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RECRUITING
NCT06220552
PHASE2

The Efficacy and Safety of Low-dose Radiotherapy Combined With Sintilimab and Temozolomide in Recurrent Glioblastoma

Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

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.

Official title: Low-dose Radiotherapy Combined With Sintilimab and Temozolomide in Recurrent Glioblastoma: A Single-arm, Prospective Phase II Clinical Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-12-27

Completion Date

2027-12-30

Last Updated

2024-01-24

Healthy Volunteers

No

Interventions

DRUG

Sintilimab

Sintilimab 200mg D1, Q3W

RADIATION

Low-dose Radiotherapy

Radiotherapy 1Gy/1F, D1/D2/D8/D15, Q3W

Locations (1)

Yingpeng Peng

Zhuhai, Guangdong, China