Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433869
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-04-23
Brief Title:
The Efficacy of Bevacizumab and Serplulimab Combined With Recombinant Mutant HumanTumor Necrosis FactorrmhTNF-NC in the Treatment of Malignant Ascites
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Multi-arm Phase II Clinical Study of Intraperitoneal Injection of Recombinant Human Tumor Necrosis Factor Bevacizumab Monoclonal Antibody and Serplulimab for the Treatment of Malignant Ascites Patients With Standard Therapy Failure
Status:
RECRUITING
Status Verified Date:
2024-05
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:
1 More than half of peritoneal metastases are from digestive tract Peritoneal metastasis has poor prognosis poor treatment response and limited means
2 rmhTNF-NC or bevacizumab are effective in the treatment of malignant pleuroabdominal effusion
3 There is increasing evidence that PD-1PD-L1 inhibitors in combination with vascular endothelial growth factor receptor VEGFR inhibitors have a complementary mechanism of action VEGF pathway inhibitors normalize blood vessels in tumors and promote immune cell maturation and infiltration thus playing a synergistic role with ICIs The strategy of systemic immunotherapy combined with antivascular therapy has been confirmed by several large phase III clinical trials such as IMbrave-150 Basic studies have confirmed that uncontrolled tumor vessels in peritoneal metastasis and malignant ascites microenvironment also play an important role in promoting disease progression Therefore this project intends to explore the treatment of malignant abdominal effusion by local intraperitoneal injection of bevacizumab and PD-1 on the basis of rmhTNF-NC
2 rmhTNF-NC or bevacizumab are effective in the treatment of malignant pleuroabdominal effusion
3 There is increasing evidence that PD-1PD-L1 inhibitors in combination with vascular endothelial growth factor receptor VEGFR inhibitors have a complementary mechanism of action VEGF pathway inhibitors normalize blood vessels in tumors and promote immune cell maturation and infiltration thus playing a synergistic role with ICIs The strategy of systemic immunotherapy combined with antivascular therapy has been confirmed by several large phase III clinical trials such as IMbrave-150 Basic studies have confirmed that uncontrolled tumor vessels in peritoneal metastasis and malignant ascites microenvironment also play an important role in promoting disease progression Therefore this project intends to explore the treatment of malignant abdominal effusion by local intraperitoneal injection of bevacizumab and PD-1 on the basis of rmhTNF-NC
Detailed Description:
GROUP A serplulimabPD-1 inhibitorbevacizumab GROUP B serplulimabrmhTNF-NC GROUP C serplulimabbevacizumabrmhTNF-NC
serplulimab100mgipD1D15 bevacizumab100mgipD1D15 rmhTNF-NC300IUtimeipD1D4D7D10
serplulimab100mgipD1D15 bevacizumab100mgipD1D15 rmhTNF-NC300IUtimeipD1D4D7D10
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?:
None