Clinical trial

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

Name

2023-K015

Description

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.

Trial arms

Trial start

2021-08-01

Estimated PCD

2024-07-01

Trial end

2024-07-01

Status

Active (not recruiting)

Treatment

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.

Arms:

Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients

Placebo

Placebo replaces tocilizumab and asprin in advanced NPC patients.

Arms:

Receive placebo in Advanced NPC Patients

Size

100

Primary endpoint

Tumor progression and metastasis

Five to Ten years

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2024-06-04

1 organization

1 product

1 indication

Organization

Affiliated Hospital of Nantong University

Product

Tocilizumab

Indication

Nasopharyngeal Carcinoma