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Trial Title:
Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients
NCT ID:
NCT06442709
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Conditions: Keywords:
nasopharyngeal narcinoma
metastasis
extracellular vesicles
organ-organ crosstalk
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Tocilizumab Asprin
Description:
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.
Arm group label:
Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients
Intervention type:
Other
Intervention name:
Placebo
Description:
Placebo replaces tocilizumab and asprin in advanced NPC patients.
Arm group label:
Receive placebo in Advanced NPC Patients
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.
Criteria for 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
Gender:
All
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Bo You
Address:
City:
Nantong
Zip:
226000
Country:
China
Start date:
August 1, 2021
Completion date:
July 1, 2024
Lead sponsor:
Agency:
Affiliated Hospital of Nantong University
Agency class:
Other
Source:
Affiliated Hospital of Nantong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06442709
