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RECRUITING
NCT06433869
PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-12-14

Completion Date

2026-12-31

Last Updated

2024-05-30

Healthy Volunteers

No

Interventions

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.

Locations (3)

Cancer center of SunYat-sen University

Guangzhou, Guangdong, China

Zhang Dongsheng

Guangzhou, China

Zhang Dongsheng

Guangzhou, China