Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients

NCT06442709 | Active Not Recruiting DMC

• 1 other identifier: 2023-K015
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

nasopharyngeal narcinoma; metastasis; extracellular vesicles; organ-organ crosstalk

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Drug: Tocilizumab Asprin

Receive placebo in Advanced NPC Patients

PLACEBO COMPARATOR

Placebo replaces tocilizumab and asprin in advanced NPC patients.

Other: Placebo

Interventions

Tocilizumab Asprin DRUG

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.

Combined Anti-IL6R and Anticoagulation Therapy in Advanced NPC Patients

Placebo OTHER

Placebo replaces tocilizumab and asprin in advanced NPC patients.

Receive placebo in Advanced NPC Patients

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of NPC with distant metastasis
• Must be able to swallow tablets

You may not qualify if:

• Liver disease
• Blood disease
• Long-term use of anticoagulants

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Bo You

Nantong, Jiangsu, 226000, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bo You, Doctor

  Department of Otorhinolaryngology-Head and Neck Surgery, Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: June 4, 2024
• Study Start: August 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Two years after this clinical trial finished.
• 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.

Locations

CN (1)