Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT05386056
Status:
UNKNOWN
Last Update Posted:
2022-11-28
First Post:
2022-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pembrolizumab and Photodynamic Therapy in Previously Treated Metastatic Esophageal Squamous Cell Carcinoma
Sponsor:
Peking University
Organization:
Study Overview
Official Title:
A Phase II Study to Explore the Efficacy and Safety of Pembrolizumab and Photodynamic Therapy in Metastatic Esophageal Squamous Cell Carcinoma Failed at Least One Line of Systemic Treatment
Status:
UNKNOWN
Status Verified Date:
2022-11
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 is a phase 2 trial investigating the effect and safety of pembrolizumab and photodynamic therapy (PDT) in metastatic esophageal squamous cell carcinoma failed at least one line of systemic treatment.
The primary efficacy hypotheses are that the objective response rate (ORR) of combination of PDT and pembrolizumab could be improved compared with pembrolizumab for both primary and metastatic lesions.
The primary efficacy hypotheses are that the objective response rate (ORR) of combination of PDT and pembrolizumab could be improved compared with pembrolizumab for both primary and metastatic lesions.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: