Actively Recruiting
A Single-Arm Phase II Study of Lucanoximab Combined with Tagolimab as Neoadjuvant Therapy for Resectable Head and Neck Squamous Cell Carcinoma
Led by West China Hospital · Updated on 2026-05-13
30
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Sacituzumab govitecan and Tagitanlimab as a neoadjuvant treatment for patients with resectable head and neck squamous cell carcinoma (HNSCC). This Phase II, single-arm, open-label study aims to assess how well this combined therapy works in shrinking tumors before surgery, its safety, and potential biomarkers related to its effectiveness. The study also looks at participants' response rates, survival time, and quality of life. Participants will receive two cycles of intravenous Sacituzumab govitecan (5 mg/kg) and Tagitanlimab (900 mg) every two weeks. Surgical removal of the tumor and nearby lymph nodes will occur 3 to 6 weeks after completing the neoadjuvant treatment. Following surgery, patients will start adjuvant therapy 4 to 6 weeks later. Those with high-risk pathological findings will receive concurrent chemoradiotherapy plus 15 cycles of Tagitanlimab as adjuvant immunotherapy, while others with general risk factors will receive radiotherapy combined with the same Tagitanlimab regimen. During the study, participants will regularly visit the clinic for physical exams, laboratory tests, and imaging scans like MRI or CT of the head and neck. They will also provide biological samples such as blood, tumor tissue, saliva, and feces at set times for biomarker analysis. Quality-of-life questionnaires will be completed to monitor daily functioning. The main outcome measured is the major pathological response rate at surgery, with additional assessments of response rate, survival, treatment side effects, and quality of life over months to years of follow-up.
CONDITIONS
Brief 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, of any gender
- Histopathologically confirmed resectable head and neck squamous cell carcinoma, excluding nasopharyngeal, salivary gland, and thyroid malignant tumors
- Surgically assessed as resectable or potentially resectable
- ECOG performance status score of 0, 1, or 2
- Adequate organ and bone marrow function meeting specified blood counts and liver, kidney, and coagulation test limits
- Voluntarily agree to participate, sign informed consent, and comply with study visits and procedures
You will not qualify if you...
- History of other malignant tumors within past 5 years, except cured non-recurrent cancers like basal cell carcinoma or cervical carcinoma in situ
- Active autoimmune disease or relevant history, except stable type 1 diabetes under insulin therapy
- History of allergic diseases or severe drug allergy, known hypersensitivity to study drugs or their components
- Previous anti-PD-1/PD-L1, anti-CTLA-4, TROP2 ADCs, or anti-tumor vaccine treatments
- 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 or immunosuppressants use within 14 days before first dose (except inhaled, topical, or adrenal replacement therapy)
- Severe heart conditions including NYHA class II or higher heart failure, ischemic heart disease, arrhythmias needing intervention, LVEF <50%, or prolonged QTc
- Known or suspected interstitial lung disease, active or uncontrolled tuberculosis
- Hyperthyroidism or organic thyroid disease (hypothyroidism under stable therapy allowed)
- Active infection, unexplained fever within 48 hours before first dose, or recent systemic antibiotics
- Active hepatitis B or C, positive HIV or AIDS history
- History of neurological or psychiatric diseases such as epilepsy or dementia
- History of drug or alcohol abuse
- Pregnant or lactating females, or those planning pregnancy or refusing contraception during and 3 months after study
- Participation in other investigational drug studies within 4 weeks before first dose
- Other unsuitable conditions as judged by investigator
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 visit (in-person)
Duration - Approximately 4 weeks
Participants receive combination neoadjuvant therapy with Sacituzumab Govitecan and Tagitanlimab given intravenously every 2 weeks for 2 cycles before surgery.
2 infusion visits every 2 weeks
Duration - Surgery occurs once within a 3 to 6 week window post-treatment
Participants undergo surgical resection of the primary tumor and regional lymph nodes within 3 to 6 weeks after completing neoadjuvant therapy.
1 surgery visit (in-person)
Duration - Duration varies based on therapy, including up to 15 cycles of Tagitanlimab
Participants receive postoperative adjuvant therapy starting 4 to 6 weeks after surgery, which may include chemoradiotherapy plus Tagitanlimab immunotherapy or radiotherapy plus Tagitanlimab depending on pathological risk factors.
Multiple visits during adjuvant therapy over several months
Duration - Up to 5 years
Participants are followed for event-free survival and overall survival with regular visits for up to 5 years after the first dose, including safety and quality of life assessments.
Visits every 3-4 months for years 1-2, every 6 months for years 3-5, then annually thereafter
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
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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