NCT06433869

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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)

Conditions

• Malignant Ascites

Interventions

Type	Name	Description
DRUG	serplulimab	Additional intraperitoneal injection of bevacizumab or rmhTNF-NC is added to the PD-1 inhibitor.
DRUG	Bevacizumab	Intraperitoneal injection of bevacizumab is added to PD-1 inhibitor or rmhTNF-NC.
DRUG	rmhTNF-NC	Intraperitoneal injection of rmhTNF-NC is added to PD-1 inhibitor or bevacizumab.

Timeline

• Start date: 2023-12-14
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-05-30
• Last updated: 2024-05-30

Locations

3 sites across 1 country: China