Actively Recruiting
Sacituzumab Tirumotecan and Toripalimab in the First-line Treatment of HNSCC
Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Updated on 2025-07-31
39
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single center, non controlled, prospective phase II clinical trial to evaluate the efficacy and safety of Sacituzumab Tirumotecan and Toripalimab in the first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma patients with trop2 and CPS positive. The participants would receive Sacituzumab Tirumotecan and Toripalimab until termination criteria are met.
CONDITIONS
Official Title
Sacituzumab Tirumotecan and Toripalimab in the First-line Treatment of HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years, any gender
- Histologically or cytologically confirmed newly diagnosed locally advanced, recurrent, or metastatic head and neck squamous cell carcinoma not curable by local treatment
- No prior anti-tumor systemic treatment for recurrent or metastatic disease; previous systemic treatment for locally advanced tumor allowed if more than 6 months have passed
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- At least one measurable lesion according to RECIST 1.1 criteria, including lesions that progressed after radiotherapy
- Availability of tumor tissue for PD-L1 and TROP2 testing within 2 years or fresh tissue
- PD-L1 combined positive score (CPS) of 1 or higher and positive TROP2 expression
- For oropharyngeal cancer, P16 status detected by immunohistochemistry
- Normal major organ function within 2 weeks before treatment, including:
- Hemoglobin ≥ 100 g/L, white blood cell count ≥ 4.0×10⁹/L or neutrophils ≥ 2.0×10⁹/L, platelet count ≥ 100×10⁹/L without blood transfusion or growth factor support
- Serum total bilirubin ≤ 1.5× upper limit of normal, AST and ALT ≤ 1.5× upper limit of normal
- Serum creatinine < 1.5× upper limit of normal or creatinine clearance ≥ 60 ml/min, blood urea nitrogen ≤ 200 mg/L
- Urinary protein less than +; if +, 24-hour total protein less than 500 mg
- Blood glucose within normal range or stable control if diabetic
- No myocardial infarction within 1 year, no unstable angina, severe arrhythmia, or cardiac insufficiency
- Negative pregnancy test within 7 days before first treatment for women of childbearing age
- Use of highly effective contraception for participants with reproductive potential during study and 12 months after treatment
- Voluntary participation with signed informed consent, good compliance, and ability to cooperate with follow-up
- Considered likely to benefit from treatment by the investigator
You will not qualify if you...
- Disease progression within 6 months after systemic treatment for locally advanced head and neck squamous cell carcinoma
- History of primary nasopharyngeal carcinoma
- Central nervous system metastasis or carcinomatous meningitis
- Hearing loss grade 2 or higher, or neuropathy grade 2 or higher while receiving anti-tumor treatment
- Participation in other drug or therapy clinical trials within 4 weeks before first treatment
- Use of hematopoietic stimulating factors within 1 week before first treatment
- Positive HIV or Treponema pallidum antibody tests
- Active hepatitis B or C infection with elevated viral markers
- Active lung diseases or history of active pulmonary tuberculosis
- Any active or history of autoimmune disease requiring systemic treatment, except specified exceptions
- Use of immunosuppressants or systemic corticosteroids over 10 mg prednisone (or equivalent) within 2 weeks before enrollment
- Uncontrolled clinical problems including severe infections, poorly controlled diabetes, severe cardiac disease, recent thromboembolism or myocardial infarction, or unstable angina
- Large symptomatic pleural effusion or ascites requiring treatment
- Use of CYP3A4 inhibitors within 1 week before screening
- History of stem cell or organ transplantation
- History of psychoactive substance abuse or mental disorder affecting compliance
- Other severe acute or chronic medical conditions or lab abnormalities increasing study risk or interfering with results
- Poor compliance or other conditions deemed unsuitable by the investigator
- History of other malignant tumors within 5 years except cured basal cell carcinoma, squamous cell carcinoma of skin, early prostate cancer, or carcinoma in situ of cervix
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
G
Guoxin Ren, M.D.
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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