Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients

May 28, 2024 updated by: Affiliated Hospital of Nantong University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nantong, Jiangsu, China, 226000
        • Bo You

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Placebo Comparator: Receive placebo in Advanced NPC Patients
Placebo replaces tocilizumab and asprin in advanced NPC patients.
Other: Placebo
Placebo replaces tocilizumab and asprin in advanced NPC patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Five to Ten years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Nantong University

Investigators

  • Principal Investigator: Bo You, Doctor, Department of Otorhinolaryngology-Head and Neck Surgery, Affiliated Hospital of Nantong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Estimated)

June 4, 2024

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-K015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code will be shared to other researchers.

IPD Sharing Time Frame

Two years after this clinical trial finished.

IPD Sharing Access Criteria

Researchers must clearly state the purpose of their study and ensure it aligns with the scientific objectives of the data sharing initiative. A detailed research plan, including research design, data analysis methods, and expected results, should be provided to ensure the data is used in a reasonable and effective manner. Additionally, researchers must outline data security and privacy protection measures to ensure the safe storage, transmission, and use of the data in compliance with relevant regulations and policies.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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