Actively Recruiting
Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma
Led by West China Hospital · Updated on 2026-05-13
30
Participants Needed
1
Research Sites
255 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the anti-tumor activity, safety and tolerability of the combination of Sacituzumab govitecan and Tagitanlimab as neoadjuvant therapy in patients with resectable head and neck squamous cell carcinoma (HNSCC). It will also explore potential biomarkers related to the efficacy of this combined therapy. The main questions it aims to answer are: Does the combination of Sacituzumab govitecan and Tagitanlimab improve the major pathological response rate (MPR) in patients with resectable HNSCC? What adverse reactions (side effects) do participants experience when receiving this combined neoadjuvant therapy? Does this combined therapy improve participants' objective response rate (ORR), survival time and quality of life? This is a single-arm, open-label, prospective Phase II clinical study conducted at West China Hospital of Sichuan University. A total of 30 eligible patients will be enrolled, and no placebo control will be used. The study will evaluate the efficacy and safety of the combined therapy by monitoring clinical indicators, pathological results and adverse events throughout the trial. Participants will: Receive Sacituzumab govitecan (5mg/kg) and Tagitanlimab (900mg) intravenously every 2 weeks, for a total of 2 treatment cycles. Patients will undergo surgical resection 3-6 weeks after completion of neoadjuvant therapy. Adjuvant therapy (concurrent chemoradiotherapy or radiotherapy alone) will be administered according to pathological risk factors, together with 15 cycles of Tagitanlimab as adjuvant immunotherapy. Visit the clinic regularly for physical examinations, laboratory tests (such as blood routine, liver and kidney function), imaging examinations (such as head and neck MRI/CT) and safety checkups according to the study schedule. Provide biological samples (peripheral blood, tumor tissue, saliva, feces) at specified time points for biomarker detection. Complete quality-of-life questionnaires (such as EORTC QLQ-C30) regularly to assess changes in daily functioning. Note: Participants will not be charged for the study drugs (Sacituzumab govitecan and Tagitanlimab ), and will receive appropriate subsidies for study-related visits and blood collection. The research team will provide active treatment and corresponding compensation if participants experience study-related adverse reactions.
CONDITIONS
Official Title
Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years and above, any gender
- Histopathologically confirmed resectable head and neck squamous cell carcinoma, excluding nasopharyngeal, salivary gland, and thyroid tumors
- Surgically assessed as resectable or potentially resectable
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Adequate organ and bone marrow function meeting specified blood count, liver, kidney, and coagulation parameters
- Voluntary participation with signed informed consent and ability to comply with study visits and procedures
You will not qualify if you...
- History of other malignant tumors within past 5 years, except certain cured and non-recurrent cancers
- Active autoimmune disease or relevant medical history except stable type 1 diabetes
- History of severe allergies or hypersensitivity to study drugs or their components
- Prior treatment with anti-PD-1/PD-L1, anti-CTLA-4 antibodies, TROP2 ADCs, or tumor vaccines
- Receipt of live infectious vaccine within 4 weeks before first dose or planned vaccination during study
- Major surgery or severe trauma within 4 weeks before first dose
- Systemic corticosteroids above 10 mg/day prednisone equivalent or immunosuppressants within 14 days before first dose
- Severe heart conditions including NYHA class II or higher heart failure, ischemic heart disease, arrhythmias, low ejection fraction, or prolonged QTc
- Known or suspected interstitial lung disease or active/uncontrolled tuberculosis
- Hyperthyroidism or organic thyroid disease (stable hypothyroidism allowed)
- Active infection, unexplained fever within 48 hours before first dose, or recent antibiotic use
- Active hepatitis B or C, positive HIV, or history of AIDS
- History of neurological or psychiatric diseases like epilepsy or dementia
- History of drug or alcohol abuse
- Pregnant or lactating females, or those unwilling to use effective contraception during and 3 months after study
- Use of other investigational drugs within 4 weeks before first dose or concurrent participation in other interventional studies
- Any condition the investigator deems unsuitable for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
H
Hong-Shuai Li, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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