Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients

Not Applicable

Active, not recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Tocilizumab Asprin; Other: Placebo

• Registration Number: NCT06442709
• Lead Sponsor: Affiliated Hospital of Nantong University

Brief Summary

The investigators have demonstrated the crucial role of the liver-lung axis in the distant metastasis of NPC. Furthermore, the investigators have identified a potential therapeutic approach to improve outcomes in NPC patients by identifying those most suitable for anticoagulant therapy. Further, the combination of anticoagulant therapy and anti-IL6R therapy has shown promising results in enhancing the prognosis of NPC patients. These findings highlight the significance of targeting the liver-lung axis and utilizing personalized treatment strategies for NPC.

Detailed Description

Distant metastasis accounts for nasopharyngeal carcinoma (NPC)-related mortalities. Recently, extracellular vesicles (EVs) have been widely explored as key mediators of bidirectional tumor-host cell interactions by mediating pre-metastatic niche (PMN) formation. However, considering the complexity of the human body, multiple organ studies of tumor metastasis remain poorly understood. Here, the investigators have demonstrated the crucial role of the liver-lung axis in the distant metastasis of NPC. The investigators demonstrated mechanistically that hepatocellular derived EVs can be specifically taken up by the lung to form a hypercoagulable pre-metastatic microenvironment associated with IL6.Furthermore, the investigators have identified a potential therapeutic approach to improve outcomes in NPC patients by identifying those most suitable for anticoagulant therapy. Further, the combination of anticoagulant therapy and anti-IL6R therapy has shown promising results in enhancing the prognosis of NPC patients. These findings highlight the significance of targeting the liver-lung axis and utilizing personalized treatment strategies for NPC.

Study Timeline

• Study Start: 2021-08-01
• Status Verified: 2024-03
• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-05-28
• Last Update Submitted: 2024-05-28
• Study First Posted: 2024-06-04
• Last Update Posted: 2024-06-04
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Clinical diagnosis of NPC with distant metastasis
• Must be able to swallow tablets

Exclusion Criteria

• Liver disease
• Blood disease
• Long-term use of anticoagulants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients	Tocilizumab Asprin	Tocilizumab, an IL6R inhibitor, injected once a month at a dose of 4mg/kg in advanced NPC patients. Asprin，an anticoagulant, taken orally once daily at a dose of 100mg in advanced NPC patients.
Receive placebo in Advanced NPC Patients	Placebo	Placebo replaces tocilizumab and asprin in advanced NPC patients.

Primary Outcome Measures

Name	Time	Method
Tumor progression and metastasis	Five to Ten years	After the patients are diagnosed and treated, CT scans is used semi-annually to determine the progression and metastasis of tumor.

Trial Locations

Locations (1)

Bo You; 🇨🇳 Nantong, Jiangsu, China