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RECRUITING
NCT06349837
PHASE1

Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients With Bulky Tumors

Sponsor: Sichuan University

View on ClinicalTrials.gov

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

DRUG

Tislelizumab

Patients will receive treatment with Tislelizumab (200 mg, iv, d1), every 3 weeks for a maximum of 48 months.

RADIATION

Low Dose Radiotherapy

LDRT (d1-d3): 6Gy/3f with conventional external beam radiation.

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