Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT05498805
Status:
UNKNOWN
Last Update Posted:
2022-08-12
First Post:
2022-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PD-1 Inhibitors With or Without Radiation in Advanced Melanoma
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
A Randomized Controlled Phase II Trial of PD-1 Inhibitors With or Without Radiation in Patients With Advanced Melanoma
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
NOT_YET_RECRUITING
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 trial was a single-center, prospective, randomized controlled phase II trial. The objective was to evaluate the efficacy and safety of PD-1 inhibitors with or without radiotherapy in patients with advanced melanoma. At the same time, tissue and peripheral blood samples of patients were collected for the determination of PD-L1 expression, ctDNA and other biomarkers and results analysis to find prognostic or curative effect predictors. A total of 92 patients were planned to be enrolled in this study.
Patients with advanced melanoma who met the inclusion criteria but did not meet the exclusion criteria were enrolled in the study and received PD-1 inhibitors with or without radiotherapy.
Patients with advanced melanoma who met the inclusion criteria but did not meet the exclusion criteria were enrolled in the study and received PD-1 inhibitors with or without radiotherapy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: