Actively Recruiting
Cetuximab + Tislelizumab + Chemotherapy in the Treatment of Unresectable LA HNSCC
Led by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Updated on 2025-05-18
42
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective, single-arm, Phase II study aims to evaluate the efficacy, safety, and surgical conversion rate of Cetuximab combined with Tislelizumab and chemotherapy for unresectable LA HNSCC.
CONDITIONS
Official Title
Cetuximab + Tislelizumab + Chemotherapy in the Treatment of Unresectable LA HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agrees to participate and can comply with study procedures
- Diagnosed with locally advanced head and neck squamous cell carcinoma confirmed by cytology or histology
- Tumor is difficult to completely remove by surgery
- No prior treatment for head and neck squamous cell carcinoma
- No prior use of cetuximab or PD-(L)1 inhibitors
- At least one measurable tumor lesion according to RECIST v1.1
- No gender restriction, age 18 years or older
- ECOG performance status score of 0 or 1
- Expected survival of at least 3 months
- Adequate organ function including blood counts, liver and kidney function, and cardiac function with LVEF >50%
- Women of childbearing potential must have a negative pregnancy test within 7 days before enrollment and agree to use effective contraception during and for 8 weeks after treatment
You will not qualify if you...
- Previous anti-tumor treatments received, including chemotherapy, radiotherapy, surgery, or immunotherapy
- Known or suspected allergy to cetuximab, PD-(L)1 antibodies, paclitaxel, or cisplatin
- Uncontrolled hypertension or significant heart disease including grade II coronary heart disease, grade II arrhythmia, or grade I cardiac insufficiency
- History of autoimmune diseases, immunodeficiency, or organ transplantation
- Active hepatitis B or hepatitis C infection
- Active tuberculosis infection
- Major surgery within 4 weeks before first dose or unhealed wounds
- Bleeding tendencies
- Severe complications such as pyloric obstruction, gastrointestinal bleeding or perforation, obstructive jaundice, or severe malnutrition
- Abdominal fistula, gastrointestinal perforation, or abscess within 6 months before enrollment
- Tumor invading important blood vessels or high risk of fatal bleeding
- History of interstitial lung disease, non-infectious pneumonia, or uncontrolled lung diseases
- Active brain metastasis
- Other malignant tumors within 5 years except cured cervical carcinoma in situ or certain skin cancers
- Pregnant or breastfeeding women
- Severe concomitant diseases endangering safety or study completion, or judged unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
Research Team
J
Juan Li
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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