Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients

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: Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: Tocilizumab Asprin; Other: Placebo

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

• 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

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: metastasis; extracellular vesicles; nasopharyngeal narcinoma; organ-organ crosstalk
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• 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