RecruitingPhase 1NCT06349837

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

Safety and Tolerability of Low Dose Radiotherapy Plus Concurrent Partial Stereotactic Ablative Radiotherapy (Eclipse-RT) and Tislelizumab in Patients With Bulky Tumors


Sponsor

Sichuan University

Enrollment

24 participants

Start Date

Apr 18, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Low Dose Radiotherapy, Stereotactic Ablative Radiotherapy, and others for people with solid tumor. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab

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

RADIATIONLow Dose Radiotherapy

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

RADIATIONStereotactic Ablative Radiotherapy

Partial SBRT at dose escalation levels: 24Gy/3f, 30Gy/3f, 45Gy/3f.


Locations(1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

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NCT06349837


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