Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06349837
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-31
Brief Title:
Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients With Bulky Tumors
Sponsor:
Sichuan University
Organization:
Sichuan University
Study Overview
Official Title:
Safety and Tolerability of Low Dose Radiotherapy Plus Concurrent Partial Stereotactic Ablative Radiotherapy Eclipse-RT and Tislelizumab in Patients With Bulky Tumors
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a 33 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
Detailed Description:
This is 33 escalation phase I study which will be conducted in West China Hospital
3 patients per cohort a total of 9 patients will be enrolled to observe the dose-limiting toxicity DLT and recommended dose for expansion RDE for lung LDRT and partial SBRT
All eligible patients will receive LDRT partial SBRT and Tislelizumab at different dose levels decried as below Tislelizumab will be given at 200mg as recommended in the instruction manual every 3 weeks until disease progression unacceptable toxicities the patient withdraws informed consent or Tislelizumab reaches a maximum of up to 24 months Patients in the dose escalation will receive LDRT partial SBRT at 3 cohorts with increasing dose levels 6 Gy 2 Gyf 24 Gy 8 Gyf 6 Gy 2 Gyf 30 Gy 10 Gyf 6 Gy 2 Gyf 45 Gy 15 Gyf
3 patients per cohort a total of 9 patients will be enrolled to observe the dose-limiting toxicity DLT and recommended dose for expansion RDE for lung LDRT and partial SBRT
All eligible patients will receive LDRT partial SBRT and Tislelizumab at different dose levels decried as below Tislelizumab will be given at 200mg as recommended in the instruction manual every 3 weeks until disease progression unacceptable toxicities the patient withdraws informed consent or Tislelizumab reaches a maximum of up to 24 months Patients in the dose escalation will receive LDRT partial SBRT at 3 cohorts with increasing dose levels 6 Gy 2 Gyf 24 Gy 8 Gyf 6 Gy 2 Gyf 30 Gy 10 Gyf 6 Gy 2 Gyf 45 Gy 15 Gyf
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None