Actively Recruiting
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
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-03-03
268
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to give informed consent for the study
- Male or female aged 18 to 80 years
- Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
- Pathologically confirmed non-metastatic squamous cell carcinoma of the head and neck
- Achieved major pathological response after surgery with neoadjuvant immunotherapy combined with chemotherapy
- Adequate bone marrow, liver, and kidney function as defined by specific laboratory values
You will not qualify if you...
- Metastatic or unresectable squamous cell carcinoma of the head and neck
- Active autoimmune disease requiring systemic treatment or history of severe autoimmune disease
- Active hepatitis B or C infection, positive HIV test, or acquired immunodeficiency syndrome
- Interstitial or non-infectious pneumonitis, active or uncontrolled pulmonary tuberculosis
- Active infection requiring systemic therapy
- Received investigational drugs within 4 weeks prior to first dose or enrolled in another clinical trial
- Any other conditions deemed unsuitable for the study by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
X
Xudong Wang, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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