Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients

NCT ID: NCT06442709

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2024-07-01

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients

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.

Group Type: EXPERIMENTAL

Tocilizumab Asprin

Intervention Type: DRUG

Tocilizumab alone, Asprin alone, Tocilizumab combined with 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 replaces tocilizumab and asprin in advanced NPC patients.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo replaces tocilizumab and asprin in advanced NPC patients.

Interventions

Tocilizumab Asprin

Tocilizumab alone, Asprin alone, Tocilizumab combined with 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.

Intervention Type: DRUG

Placebo

Placebo replaces tocilizumab and asprin in advanced NPC patients.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bo You, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Otorhinolaryngology-Head and Neck Surgery, Affiliated Hospital of Nantong University

Locations

Bo You

Nantong, Jiangsu, China

Countries

China

Other Identifiers

2023-K015

Identifier Type: -

Identifier Source: org_study_id