Actively Recruiting
Immune Maintenance Therapy Study in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma After Neoadjuvant Immunotherapy and Chemotherapy
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-03-03
268
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating immune maintenance therapy in patients with locally advanced head and neck squamous cell carcinoma who have achieved a major pathological response (MPR) after receiving neoadjuvant immunotherapy combined with chemotherapy. This study addresses the high morbidity and mortality of head and neck cancer, where standard treatments offer limited clinical benefit and survival rates are low. The goal is to assess the effectiveness and safety of this immune maintenance treatment following initial therapy. The study compares two groups: one receiving toripalimab as immune maintenance therapy intravenously at 240 mg every three weeks for up to 15 cycles, and the other receiving standard concurrent radiochemotherapy or postoperative radiotherapy. This phase II trial is randomized and conducted at a single center, focusing on patients who have already responded well to initial combined neoadjuvant immunotherapy and chemotherapy. Participants will be monitored for disease-free survival for up to four years, with additional evaluations of overall survival and adverse events for up to one year. The study involves regular assessments of physical health, laboratory tests for bone marrow, liver, and kidney function, and safety monitoring. Follow-up visits will include evaluations of treatment response and potential side effects to ensure participant safety throughout the trial period.
CONDITIONS
Brief 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 Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Pathologically confirmed non-metastatic squamous cell carcinoma of head and neck (SCCHN)
- Achieved major pathological response (MPR) after surgery with neoadjuvant immunotherapy combined with chemotherapy
- Adequate bone marrow, liver, and renal function with specific laboratory values: absolute neutrophil count ≥ 1.5 x 10^9/L, hemoglobin ≥ 9.0 g/dL, platelets ≥ 100000/μL; ALT and AST < 2.5x upper limit of normal, total bilirubin ≤ 1.5x upper limit of normal; creatinine clearance ≥ 60 ml/min; APTT ≤ 1.5x upper limit of normal
You will not qualify if you...
- Metastatic or unresectable squamous cell carcinoma of 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 pneumonitis, non-infectious pneumonitis, active or uncontrolled pulmonary tuberculosis
- Active infection requiring systemic therapy
- Received investigational drug within 4 weeks prior to first dose or concurrent enrollment in another clinical trial
- Any other factors judged unsuitable for study inclusion by investigators
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 45 weeks (15 cycles of 3 weeks each)
Participants receive Toripalimab intravenously every 3 weeks for up to 15 cycles or standard concurrent radiochemotherapy or postoperative radiotherapy according to their assigned treatment arm.
Up to 15 visits every 3 weeks
Duration - Up to 4 years
Participants are monitored for disease-free survival, overall survival, and adverse events following treatment completion.
Periodic follow-up visits over 4 years
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.
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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