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NCT06208826Recruiting

A Single-center Phase II Study to Investigate the Immune Maintenance Therapy Pattern in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Who Have Achieved MPR After Neoadjuvant Immunotherapy Combined With Chemotherapy

Tianjin Medical University Cancer Institute and HospitalPhase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Head and Neck Cancer
Drug/Device/Intervention
Toripalimab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Tianjin Medical University Cancer Institute and Hospital
Location
Tianjin, China
Timeline & enrollment
Phase
Phase 2
Start date
Sep 01, 2023
End date
Sep 01, 2028
Enrollment
268 participants
Primary outcome

Disease Free Survival

Summary

Head and neck cancer is the malignant tumor with the highest morbidity and mortality, of
 which 60% present with locally advanced disease at initial diagnosis, and the 5-year survival
 rate of standard treatment is less than 30%. Standard of care (SOC) including adjuvant and
 neoadjuvant therapy can provides only about 5-10% clinical benefit. According to the
 available data on the application of immunotherapy as adjuvant therapy in operable patients,
 adjuvant immunotherapy is safe and feasible, with a significant trend of benefit. Based on
 the above positive and meaningful clinical needs and scientific basis, it is very necessary
 to carry out clinical trials of adjuvant immunotherapy. The primary objective of this study
 is to evaluate the efficacy and safety of immune maintenance therapy in patients with locally
 advanced head and neck squamous cell carcinoma who achieve MPR after neoadjuvant
 immunotherapy combined with chemotherapy.

ICD-10 classifications
Malignant neoplasm of other and ill-defined sites: Head, face and neckMalignant neoplasm: Skin of scalp and neckMalignant neoplasm: Connective and soft tissue of head, face and neckCarcinoma in situ: Skin of scalp and neckSecondary and unspecified malignant neoplasm: Lymph nodes of head, face and neck
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06208826
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06208826 through Pure Global AI's free database. This Phase 2 trial is sponsored by Tianjin Medical University Cancer Institute and Hospital and is currently Recruiting. The study focuses on Head and Neck Cancer. Target enrollment is 268 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.