Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483347
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-23
Brief Title:
Checkpoint Inhibitor Combinations Therapy as First Line for Inoperable Lung Cancer Via IT
Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Organization:
Second Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
Intra-tumor Delivery of Double Checkpoint Inhibitors Chemodrug andor Bevacizumab Therapy as First Line for Inoperable Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
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:
This trial is designed to investigate the safety response rates and survival outcomes of patients with inoperable lung cancer by infusion of CTLA4 PD1 and PDL1 antibodies combination with chemodrug orand bevacizumab through intra-tumor IT
Detailed Description:
Antibodies against CTLA4 PD1 and PDL1 are representative drugs for the check-points inhibitory agents and their clinical indications have been approved in various types of tumors including advanced melanoma non-small cell lung cancer renal cell carcinoma and classical Hodgkins lymphoma and late recurrent head and neck squamous cell carcinoma patients et al Those drugs are regularly systemically administrated by vein infusion however local delivery of those drugs via interventional radiology technique including trans-artery or intra-tumor injection may increase the local drug concentration of the tumor improve the efficacy and reduce systemic adverse reactions CTLA4 antibody ipilimumab has been widely effectively using to combine with PD1 or PDL1 antibody and this study is to combine ipilimumab and PD1 antibody or PDL1 antibody so called double checkpoint inhibitors combination therapy as first line for inoperable lung cancer via intra-tumor admistration To the investigators knowledge no studies have been developed on the safety efficacy and survival benefit of the double checkpoint inhibitors combination therapy for cancer patients as first line via intra-tumor delivery
This phase II clinical trial is designed to assess the safety and survival benefit of ipilimumab and pembrolizumab or durvalumab combination with or without chemodrug or bevacizumab as first line therapy on patients with inoperable lung cancer including PFS ORR DCR and median survival time
This phase II clinical trial is designed to assess the safety and survival benefit of ipilimumab and pembrolizumab or durvalumab combination with or without chemodrug or bevacizumab as first line therapy on patients with inoperable lung cancer including PFS ORR DCR and median survival time
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?:
None