Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06190782
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2023-12-20
Brief Title:
Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Phase III Randomized-controlled Study of PD-1 Inhibitor Combined With Local Therapy in Patients With Oligometastatic Esophageal Squamous Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Patients with oligometastatic squamous cell carcinoma were enrolled and randomly assigned to receive either PD-1 inhibitor - chemotherapy combined with local therapy or PD-1 inhibitor - chemotherapy alone
The primary end point was progression-free survival PFS The secondary end points included overall survival side effects and local control
The primary end point was progression-free survival PFS The secondary end points included overall survival side effects and local control
Detailed Description:
Patients with oligometastatic squamous cell carcinoma were enrolled and 21 randomly assigned to receive either PD-1 inhibitor - chemotherapy combined with local therapy radiotherapy surgery radiofrequencymicrowave ablation etc or PD-1 inhibitor - chemotherapy alone Different local therapy techniques are allowed to be used on different lesions in the same patientAll suspected malignant lesion should be included in local treatment planning in principle
The primary end point was progression-free survival PFS The second end points included overall survival side effects and local control
The primary end point was progression-free survival PFS The second end points included overall survival side effects and local control
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