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Clinical Trials/NCT06442709
NCT06442709Active, not recruitingNot Applicable

Combined Anti-IL6R and Anticoagulation Therapy Improves Prognosis in Patients With Advanced Nasopharyngeal Carcinoma

Affiliated Hospital of Nantong University1 site in 1 country100 target enrollmentStarted: August 1, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
100
Locations
1
Primary Endpoint
Tumor progression and metastasis

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients

Experimental

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: Tocilizumab Asprin (Drug)

Receive placebo in Advanced NPC Patients

Placebo Comparator

Placebo replaces tocilizumab and asprin in advanced NPC patients.

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

Tumor progression and metastasis

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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