Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05520853
Status:
RECRUITING
Last Update Posted:
2022-08-30
First Post:
2022-08-27
Brief Title:
SBRT Combined With PD-1 Inhibitor and Thoracic Hyperthermia for Advanced NSCLC
Sponsor:
First Peoples Hospital of Hangzhou
Organization:
First Peoples Hospital of Hangzhou
Study Overview
Official Title:
An Open Single-arm Multicenter Phase II Trial to Evaluate SBRT Combined With PD-1 Inhibitors and Thoracic Hyperthermia for Advanced Non-Small-Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2022-08
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:
The aim of this trial is to investigate the primary efficacy of SBRT combined with PD-1 inhibitor and thoracic hyperthermia in patients with EGFR ALK and ROS1 negative stage IV NSCLC patients who progressed after first-line treatment At least one lesion primary or metastatic was selected for SBRT treatment and the radiotherapy dose of each lesion was 32Gy4Fx SBRT was combined with thoracic hyperthermia from the first fraction and hyperthermia was performed 6 times twice a week PD-1 inhibitor was used on the second day after the completion of SBRT The PD-1 inhibitor was administered at a dose of 200mg every time every 3 weeks for 2 years 35 times total or until the investigators deem that the patient need to discontinue the drug because of treatment-related toxicity or disease progression During the period the overall response rate and toxicities were regularly evaluated
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None