University of Saskatchewan — Biomedical Watch V2

Traitements5programmes

Essais2liés

Publications4liées

SourceDBlocale

Traitements

5

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
IRE plus checkpoint inhibitorThe goal of this pilot clinical trial is to learn about the combination of immune boosting drugs and irreversible electroporation (IRE) in patients with colon cancer that has spread to the liver (metastasis). The main questions it aims to answer are: 1. to document the rate of complications associated with combining IRE with immune boosting drugs. 2. After one liver metastasis is treated with IRE and immune boosting drugs, what is the change in the size of the non-IRE-treated liver metastases? 3. What is the immune response (measured in a blood sample) when IRE is combined with one or two types of immune boosting drugs?	Cancer	Phase 1/2			À vérifier
IRE plus Checkpoint Inhibitor plus CpG-ODNThe goal of this pilot clinical trial is to learn about the combination of immune boosting drugs and irreversible electroporation (IRE) in patients with colon cancer that has spread to the liver (metastasis). The main questions it aims to answer are: 1. to document the rate of complications associated with combining IRE with immune boosting drugs. 2. After one liver metastasis is treated with IRE and immune boosting drugs, what is the change in the size of the non-IRE-treated liver metastases? 3. What is the immune response (measured in a blood sample) when IRE is combined with one or two types of immune boosting drugs?	Cancer	Phase 1/2			À vérifier
Irreversible electroporation (NanoKnife® )Background Pancreatic cancer is one the leading causes of cancer-related death in Canada. Approximately 40 percent of patients with pancreatic cancer present with locally advanced pancreatic cancer and are not candidate for curative surgery. The optimal management of patients with locally advanced pancreatic cancer remains unknown. Most patients are treated with chemotherapy alone and role of local treatment such as radiation is not well defined. Other conventional ablative therapies such as thermal ablation and cryoablation have limited role in locally advanced pancreatic cancer due to the risk of collateral damage to the adjacent structures. Irreversible electroporation (IRE) is a novel non-thermal ablation technology that does not cause injury to nearby blood vessels, ducts, and bowel and has potential to provide longer disease control and thereby a better overall survival. The current study aims to prospectively validate effectiveness and safety of IRE in real-world patients with locally advanced pancreatic cancer. Objectives 1\) To determine 12-month progression-free survival (PFS) and 24-month overall survival rates of patients with locally advanced pancreatic cancer who are treated with combination chemotherapy and IRE and 2) to compare progression-free and overall survival of patients with locally advanced pancreatic cancer who are treated with combination chemotherapy and IRE versus combination chemotherapy alone. Design Prospective multicenter single arm study. Methods Based on the assumption of doubling of PFS of patients who are being treated with IRE and chemotherapy versus chemotherapy alone we estimated a sample of n=27 of adult patients with histologically proven non-metastatic locally advanced adenocarcinomas. Eligible patients will be recruited at the two major cancer centers in Saskatchewan. All IRE eligible patients will receive 12 weeks of induction chemotherapy and will undergo repeat imaging studies. If there is no disease progression IRE will be performed. An additional 12 weeks of chemotherapy will be recommended. Patients who are not eligible for IRE due to size criteria will receive chemotherapy at the discretion of treating oncologist till disease progression or till they become eligible for IRE. Quality of life will be assessed every three months or until disease progression. Significance Despite progress in the management of most solid organ cancers and better outcomes, little advancement has been made in the treatment of patients with locally advanced pancreatic cancer. Unfortunately, most patients have very limited life expectancy. There is an unmet need for novel approaches in the management of patients with locally advanced pancreatic cancer. IRE in combination with chemotherapy has potential to improve local disease control and thereby improves survival and may prove a valuable tool to add in the multidisciplinary treatment of cancer. The result of this study will be used for the development of a future multicenter national phase III trials.	Cancer	Non applicable	Ralentissement de la progression	Canada	À vérifier
IRE plus checkpoint inhibitorThe goal of this pilot clinical trial is to learn about the combination of immune boosting drugs and irreversible electroporation (IRE) in patients with colon cancer that has spread to the liver (metastasis). The main questions it aims to answer are: 1. to document the rate of complications associated with combining IRE with immune boosting drugs. 2. After one liver metastasis is treated with IRE and immune boosting drugs, what is the change in the size of the non-IRE-treated liver metastases? 3. What is the immune response (measured in a blood sample) when IRE is combined with one or two types of immune boosting drugs?	Cancer	Phase 1/2			À vérifier
Irreversible electroporation (NanoKnife® )Background Pancreatic cancer is one the leading causes of cancer-related death in Canada. Approximately 40 percent of patients with pancreatic cancer present with locally advanced pancreatic cancer and are not candidate for curative surgery. The optimal management of patients with locally advanced pancreatic cancer remains unknown. Most patients are treated with chemotherapy alone and role of local treatment such as radiation is not well defined. Other conventional ablative therapies such as thermal ablation and cryoablation have limited role in locally advanced pancreatic cancer due to the risk of collateral damage to the adjacent structures. Irreversible electroporation (IRE) is a novel non-thermal ablation technology that does not cause injury to nearby blood vessels, ducts, and bowel and has potential to provide longer disease control and thereby a better overall survival. The current study aims to prospectively validate effectiveness and safety of IRE in real-world patients with locally advanced pancreatic cancer. Objectives 1\) To determine 12-month progression-free survival (PFS) and 24-month overall survival rates of patients with locally advanced pancreatic cancer who are treated with combination chemotherapy and IRE and 2) to compare progression-free and overall survival of patients with locally advanced pancreatic cancer who are treated with combination chemotherapy and IRE versus combination chemotherapy alone. Design Prospective multicenter single arm study. Methods Based on the assumption of doubling of PFS of patients who are being treated with IRE and chemotherapy versus chemotherapy alone we estimated a sample of n=27 of adult patients with histologically proven non-metastatic locally advanced adenocarcinomas. Eligible patients will be recruited at the two major cancer centers in Saskatchewan. All IRE eligible patients will receive 12 weeks of induction chemotherapy and will undergo repeat imaging studies. If there is no disease progression IRE will be performed. An additional 12 weeks of chemotherapy will be recommended. Patients who are not eligible for IRE due to size criteria will receive chemotherapy at the discretion of treating oncologist till disease progression or till they become eligible for IRE. Quality of life will be assessed every three months or until disease progression. Significance Despite progress in the management of most solid organ cancers and better outcomes, little advancement has been made in the treatment of patients with locally advanced pancreatic cancer. Unfortunately, most patients have very limited life expectancy. There is an unmet need for novel approaches in the management of patients with locally advanced pancreatic cancer. IRE in combination with chemotherapy has potential to improve local disease control and thereby improves survival and may prove a valuable tool to add in the multidisciplinary treatment of cancer. The result of this study will be used for the development of a future multicenter national phase III trials.	Cancer	Non applicable	Ralentissement de la progression	Canada	À vérifier

Essais cliniques

2

Molécule	Indication / population	Phase	NCT	Titre	Statut
Irreversible electroporation (NanoKnife® )	Cancer	Non applicable	NCT04276857	SMART — Systemic Therapy With a Loco-regional Treatment in Patients With Locally Advanced Pancreatic Cancer	RECRUITING
IRE plus checkpoint inhibitor	Cancer	Phase 1/2	NCT06047015	Irreversible Electroporation (NanoKnife ®) and Immunotherapy for the Treatment of Stage IV Colorectal Cancer	NOT_YET_RECRUITING

Publications

4

Molécule	Indication / population	Titre	Journal	Date
Irreversible electroporation (NanoKnife® )		Irreversible electroporation in prostate cancer: efficacy, tumor immune microenvironment remodeling, and combination immunotherapy-a narrative review.	Translational andrology and urology
IRE plus checkpoint inhibitor		Irreversible Electroporation Plus Anti-PD-1 Antibody versus Irreversible Electroporation Alone for Patients with Locally Advanced Pancreatic Cancer.	Journal of inflammation research
IRE plus checkpoint inhibitor		Efficacy of irreversible electroporation combined with immunotherapy versus irreversible electroporation alone in locally advanced pancreatic cancer: a propensity score-matched retrospective study.	Frontiers in immunology
IRE plus checkpoint inhibitor		Multiparametric MRI to Predict Response to Irreversible Electroporation Plus Anti-PD-1 Immunotherapy in Pancreatic Ductal Adenocarcinoma.	Magnetic resonance in medicine