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 - Trial NCT06208826
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.
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Study Focus
Sponsor & Location
Tianjin Medical University Cancer Institute and Hospital
Timeline & Enrollment
Phase 2
Sep 01, 2023
Sep 01, 2028
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
Data Source
ClinicalTrials.gov
NCT06208826
Non-Device Trial