Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06017297
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2023-08-24
Brief Title:
Neoadjuvant Tremelimumab and Durvalumab With GemCis in Intrahepatic Cholangiocarcinoma
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
Phase II Study of Neoadjuvant Durvalumab MEDI4736 and Tremelimumab in Combination With Gemcitabine and Cisplatin in Patients With Intrahepatic Cholangiocarcinoma That is Borderline ResectableResectable But With High Risk for Recurrence
Status:
RECRUITING
Status Verified Date:
2024-09
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:
ESR-22-21719
Brief Summary:
The goal of this clinical trial is to test feasibility and safety of the combination of tremelimumab and durvalumab plus gemcitabine and cisplatin as a neoadjuvant treatment bridge patients to a curative resection in treatment naïve borderline resectable or resectable with high risk for recurrence intrahepatic cholangiocarcinoma patients The main questions it aims to answer are
What is the rate of conversion of unresectable tumor to resectable cancer
What are the side effects of this treatment combination
Participants will undergo an initial tumor biopsy imaging and laboratory studies prior to starting treatment with durvalumab tremelimumab gemcitabine and cisplatin Participants will continue for 4 cycles and if the tumor is found to be resectable then they will undergo surgical resection If the tumor is unresectable cant be surgically removed after 4 cycles then participants will receive 4 more cycles and repeated imaging If the tumor remains unresectable then the participant will be treated with capecitabine for up to 8 cycles and durvalumab for up to 12 months
What is the rate of conversion of unresectable tumor to resectable cancer
What are the side effects of this treatment combination
Participants will undergo an initial tumor biopsy imaging and laboratory studies prior to starting treatment with durvalumab tremelimumab gemcitabine and cisplatin Participants will continue for 4 cycles and if the tumor is found to be resectable then they will undergo surgical resection If the tumor is unresectable cant be surgically removed after 4 cycles then participants will receive 4 more cycles and repeated imaging If the tumor remains unresectable then the participant will be treated with capecitabine for up to 8 cycles and durvalumab for up to 12 months
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?:
False
Is an FDA AA801 Violation?:
None