Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients

Affiliated Hospital of Nantong University

Status: Active, not recruiting

Conditions: Nasopharyngeal Carcinoma

Treatments: Other: Placebo; Drug: Tocilizumab Asprin

Study type: Interventional

Funder types: Other

Identifiers

NCT06442709

2023-K015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups, including a placebo group

Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients

Experimental group

Description:

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.

Treatment:

Drug: Tocilizumab Asprin

Receive placebo in Advanced NPC Patients

Placebo Comparator group

Description:

Placebo replaces tocilizumab and asprin in advanced NPC patients.

Treatment:

Other: Placebo