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
Study ID
NCT06433869
Phase
PHASE2
Status
Recruiting
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Conditions

  • Malignant Ascites

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Dec 14, 2023
Status verified
May 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    Treat the malignant ascites by local intraperitoneal injection of PD-1 inhibitor and bevacizumab
  • Experimental: Group B
    Treat the malignant ascites by local intraperitoneal injection of PD-1 inhibitor and rmhTNF-NC
  • Experimental: Group C
    Treat the malignant ascites by local intraperitoneal injection of PD-1 inhibitor, rmhTNF-NC and bevacizumab

Primary Outcome Measure

Objective response rate of ascites [ Time Frame: 2 months ]

Central Contacts

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