Actively Recruiting
Induction IBI110 and Sintilimab with Chemotherapy in LA HNSCC
Led by Fudan University · Updated on 2025-02-25
27
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to investigate the efficacy and safety of combining sintilimab and the TP regimen with/without IBI110 for neoadjuvant chemotherapy in resectable locally advanced head and neck squamous cell carcinoma (HNSCC).
CONDITIONS
Official Title
Induction IBI110 and Sintilimab with Chemotherapy in LA HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willingness to complete the study
- Age between 18 and 75 years
- Histologically confirmed head and neck squamous cell carcinoma at specific sites (oropharynx, oral cavity, larynx, hypopharynx)
- Resectable locally advanced head and neck squamous cell carcinoma (Stage III-IVB)
- At least one measurable lesion before treatment
- Expected survival greater than 3 months
- ECOG performance status of 0 or 1
- Adequate organ function based on blood counts, liver, kidney function, and coagulation tests
- Controlled hepatitis B or C infection as specified
- Women of childbearing potential must have a negative pregnancy test and use contraception during and after the study
- Non-sterilized men must agree to use contraception during and after the study
You will not qualify if you...
- History or current presence of other malignancies except certain cured cancers with over 5 years cancer-free
- Prior investigational drug use within 4 weeks before study drug
- Participation in other clinical studies unless observational
- Recent systemic corticosteroid or immunosuppressive treatment within 2 weeks before study drug, with some exceptions
- Recent anti-tumor or live vaccination within 4 weeks before study drug
- Major surgery or severe trauma within 4 weeks before study drug
- Uncontrolled heart conditions including heart failure, unstable angina, recent heart attack, or serious arrhythmias
- Severe infections requiring hospitalization or recent significant infections
- Active autoimmune diseases or history except certain stable conditions
- History of immunodeficiency or organ/bone marrow transplant
- History of interstitial lung disease or non-infectious pneumonia
- Active or recent pulmonary tuberculosis infection
- Active hepatitis B or C infection beyond specified limits
- History of psychiatric drug abuse, alcoholism, or drug addiction
- Pregnant or breastfeeding women
- Other conditions that may affect safety or study completion as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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