Ignite Creation Date:
2024-07-17 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492408
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-02
Brief Title:
Neoadjuvant Intra-tumor Double Immunotherapy for Hepatocellular Carcinoma
Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Organization:
Second Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
Phase II Study of Neoadjuvant CT-Guided Intra-tumor Double Checkpoint Blockades for Untreated Hepatocellular Carcinoma HCC Amenable for Surgical Resection
Status:
RECRUITING
Status Verified Date:
2024-07
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 hepatocellular carcinoma by delivery of CTLA4 and PD1 or PDL1 antibodies combination through CT-guided intra-tumor IT injection
Detailed Description:
Antibodies against CTLA4 PD1 or 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 neoadjuvant therapy for hepatocellular carcinoma HCC 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 neoadjuvant treatment 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 neoaduvant therapy on patients with HCC including safety pCR mPR 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