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Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients With Bulky Tumors
Sponsor: Sichuan University
Summary
This is a 3+3 dose escalation phase I study which aims to evaluate the safety and tolerability of low dose radiotherapy (LDRT) plus concurrent partial Stereotactic Ablative Radiotherapy (SBRT) and Tislelizumab in Patients with bulky tumors who have failed standard therapy. At least 9 participants will be enrolled in this study.
Official title: Safety and Tolerability of Low Dose Radiotherapy Plus Concurrent Partial Stereotactic Ablative Radiotherapy (Eclipse-RT) and Tislelizumab in Patients With Bulky Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-04-18
Completion Date
2026-11-30
Last Updated
2025-12-17
Healthy Volunteers
No
Conditions
Interventions
Tislelizumab
Patients will receive treatment with Tislelizumab (200 mg, iv, d1), every 3 weeks for a maximum of 48 months.
Low Dose Radiotherapy
LDRT (d1-d3): 6Gy/3f with conventional external beam radiation.
Stereotactic Ablative Radiotherapy
Partial SBRT at dose escalation levels: 24Gy/3f, 30Gy/3f, 45Gy/3f.
Locations (1)
West China Hospital, Sichuan University
Chengdu, Sichuan, China