Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-13 @ 6:53 PM
Study NCT ID:
NCT06478108
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interventional Software for Multi-immunotherapy of Solid Tumors
Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Organization:
Study Overview
Official Title:
Interventional Software IRSW-MIM Guided Immunotherapy for Advanced Solid Tumors: a Phase II Clinical Trial.
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 advanced solid tumors by intra-tumor (IT) injection of multiple drugs including CTLA4, PD1, and/or PDL1 antibodies combined with drugs-eluting beads loaded with IL2, chemodrug, anti-angiogenesis drug, et. al that will be recommended by an AI-based medical software named IRSW-MIM developed by a cooperating company.
Detailed Description:
Malignant solid tumors including lung and liver cancers are the most common malignancy worldwide, and their mortality rates are very high. China has a huge population base with about 4,000,000 new cancer cases each year. More than 60% of the solid tumors in China are diagnosed at mid-to-late stage and have lost the chance of surgery. Recently a lot of therapeutic strategies have been developed and applied to clinic including targeted therapy and immunotherapy, but the overall therapeutic efficiency is still low. It is very difficult to treat patients with recurrent/refractory/metastatic advanced solid cancers and more alternative therapies are urgently needed.
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 Hodgkin's 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 or other drugs, therefore, an AI-based medical software has been developed to help to determine the detailed combinations and dosages according to personalized medical condition such as sex, body weight, key organ functions, tumor types and their PDL1 level, status of MSI and TMB, previous treatment, et. al. This software, named interventional radiology appliable software for muti-immunothepy (IRSW-MIM), will be assessed by clinical applications on cancer patients.
This phase II clinical trial is to test the the safety, efficacy and survival benefit of the IRSW-MIM guided immunotherapy for advanced solid tumors, including PFS, ORR, DCT, and median survival time.
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 Hodgkin's 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 or other drugs, therefore, an AI-based medical software has been developed to help to determine the detailed combinations and dosages according to personalized medical condition such as sex, body weight, key organ functions, tumor types and their PDL1 level, status of MSI and TMB, previous treatment, et. al. This software, named interventional radiology appliable software for muti-immunothepy (IRSW-MIM), will be assessed by clinical applications on cancer patients.
This phase II clinical trial is to test the the safety, efficacy and survival benefit of the IRSW-MIM guided immunotherapy for advanced solid tumors, including PFS, ORR, DCT, and median survival time.
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?: