The Efficacy of Bevacizumab and Serplulimab Combined With Recombinant Mutant HumanTumor Necrosis Factor(rmhTNF-NC) in the Treatment of Malignant Ascites

Malignant Ascites Clinical Trial

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

Clinical Trial 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-1/PD-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

Clinical Trial Description

GROUP A: serplulimab(PD-1 inhibitor)+bevacizumab GROUP B: serplulimab+rmhTNF-NC GROUP C:

serplulimab+bevacizumab+rmhTNF-NC

serplulimab(100mg,ip,D1、D15) bevacizumab(100mg,ip,D1、D15) rmhTNF-NC(300IU/time,ip,D1、D4、D7、D10) ;

Related Conditions & MeSH terms

• Ascites
• Malignant Ascites
• Necrosis

• NCT number: NCT06433869
• Study type: Interventional
• Source: Sun Yat-sen University
• Contact: dongsheng zhang, PHD
• Phone: 020-87343533
• Email: zhangdsh@sysucc.org.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: December 14, 2023
• Completion date: December 31, 2026