Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530823
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Pemigatinib Combined With Durvalumab for Previously Treated Biliary Tract Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pemigatinib Combined With Durvalumab for the Safety and Efficacy in Second-Line Treatment of Biliary Tract Cancer A Single-Arm Multicenter Phase II Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a single-arm multicenter Phase II clinical trial designed to preliminarily assess the safety and efficacy of the combination therapy of pemigatinib and durvalumab in the second-line treatment of patients with advanced malignant biliary tract cancer
The study anticipates enrolling 38 participants characterized by the following criteria 1 A confirmed diagnosis of advanced metastatic or unresectable biliary tract cancer by histopathological examination 2 Presence of FGFR2 fusion or rearrangement confirmed by testing 3 Prior receipt of first-line treatment for biliary tract cancer
The primary questions the study aims to address are
1 Can the combination of pemigatinib and durvalumab improve the prognosis of participants with previously treated biliary tract cancer BTC
2 What is the safety profile of the treatment with pemigatinib and durvalumab
Participants will receive
1 Oral administration of 135 mg pemigatinib once daily in combination with durvalumab 1500 mg via intravenous infusion
2 Follow-up visits will be scheduled every 6 weeks
Investigators will observe and document the objective tumor response rate of the participants as well as progression-free survival PFS disease control rate DCR overall survival OS and adverse events
The study anticipates enrolling 38 participants characterized by the following criteria 1 A confirmed diagnosis of advanced metastatic or unresectable biliary tract cancer by histopathological examination 2 Presence of FGFR2 fusion or rearrangement confirmed by testing 3 Prior receipt of first-line treatment for biliary tract cancer
The primary questions the study aims to address are
1 Can the combination of pemigatinib and durvalumab improve the prognosis of participants with previously treated biliary tract cancer BTC
2 What is the safety profile of the treatment with pemigatinib and durvalumab
Participants will receive
1 Oral administration of 135 mg pemigatinib once daily in combination with durvalumab 1500 mg via intravenous infusion
2 Follow-up visits will be scheduled every 6 weeks
Investigators will observe and document the objective tumor response rate of the participants as well as progression-free survival PFS disease control rate DCR overall survival OS and adverse events
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None