Actively Recruiting
Comparison of Efficacy Between De-escalated Surgery and Standard Surgery After Neoadjuvant Immunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Randomized, Single-center Exploratory Clinical Study
Led by Qunxing Li,MD · Updated on 2026-01-27
60
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the effectiveness and safety of less extensive (de-escalated) surgery compared to standard surgery in patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have shown a partial or complete response after neoadjuvant immunochemotherapy. The goal is to see if reducing surgery extent can maintain cancer control while improving postoperative function and quality of life. This exploratory, randomized, controlled clinical trial will enroll 60 patients over three years. Participants will be randomly assigned to either the experimental group receiving de-escalated surgery, which involves smaller tumor removal margins, preservation of key anatomical structures, and selective neck dissection based on clinical response, or the control group receiving standard surgery following established guidelines, including wide excision and comprehensive neck dissection. Imaging assessments using CT or MRI and RECIST 1.1 criteria will guide treatment decisions and monitor response at multiple time points before and after surgery. During the study, patients will undergo evaluations including imaging scans at baseline, before surgery, and regularly every three months for up to two years or until recurrence or study completion. Quality of life will be measured using specific questionnaires at baseline, one month after surgery, and during follow-ups. Researchers will track disease-free survival, overall survival rates at 3 and 5 years, and safety outcomes. The trial aims to provide evidence on whether a tailored surgical approach can improve patient quality of life without compromising survival.
CONDITIONS
Brief Title
Comparison of Efficacy Between De-escalated Surgery and Standard Surgery After Neoadjuvant Immunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with stage III-IVa head and neck squamous cell carcinoma (HNSCC) per AJCC 8th edition TNM staging
- Achieved partial or complete response after neoadjuvant immunochemotherapy with PD-1 inhibitor plus nab-paclitaxel and carboplatin/cisplatin
- No prior history of other malignant tumors
- Aged between 18 and 75 years
- Normal baseline clinical and laboratory findings including adequate blood counts, liver and kidney function, coagulation, thyroid function, and myocardial enzyme profile
- Female participants of childbearing potential must have a negative pregnancy test before treatment
- Agree to use effective contraception during treatment and for specified periods after last treatment
- Controlled adverse events from neoadjuvant therapy to grade 0-2 before surgery
- Assessed as fit for general anesthesia by anesthesiology
- Signed informed consent
You will not qualify if you...
- Diagnosis of another malignant tumor or primary lesion was not oral cancer at neoadjuvant therapy
- Active autoimmune disease requiring systemic treatment within 2 years prior to treatment
- History of allogeneic organ or hematopoietic stem cell transplantation (except corneal transplantation)
- Known HIV infection
- Untreated active hepatitis B or hepatitis C infection
- Pregnant or lactating women
- Severe or uncontrolled systemic diseases including cardiac disorders, vascular diseases, uncontrolled hypertension, pulmonary diseases, active infections, tuberculosis, gastrointestinal diseases, liver cirrhosis or active hepatitis, uncontrolled diabetes, renal dysfunction, or severe psychiatric disorders affecting treatment compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Duration of neoadjuvant therapy cycles until assessment of tumor response
Participants receive neoadjuvant immunotherapy combined with chemotherapy prior to surgery.
Visits scheduled according to treatment cycles (exact number not specified)
Duration - Surgical procedure and immediate postoperative period
Participants undergo either de-escalated surgery or standard surgery based on their response to neoadjuvant therapy.
1 surgery visit (in-person) plus immediate postoperative care
Duration - Up to 2 years or until recurrence, death, or study end
Participants are monitored for safety and recovery after surgery, including radiologic assessments and quality of life evaluations.
Follow-up visits every 3 months for up to 2 years, plus additional visits at 30 days post-surgery
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
L
Liansheng Wang, PhD (Candidate)
Q
Qunxing Li, MD, PhD
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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