Actively Recruiting
Tislelizumab Combined APF Chemotherapy in the Treatment of Locally Advanced Head and Neck Tumors
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2025-09-05
29
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test in describe participant population. The main questions it aims to answer are: 1. evaluate the efficacy and safety of tislelizumab combined with APF sequential surgery or radical concurrent chemoradiotherapy in the treatment of locally advanced head and neck tumors. 2. the exploration of efficacy-related immune microenvironment genes Participants will receive tislelizumab combined with APF sequential surgery or radical concurrent chemoradiotherapy.
CONDITIONS
Official Title
Tislelizumab Combined APF Chemotherapy in the Treatment of Locally Advanced Head and Neck Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old
- Histological or cytology-confirmed squamous cell carcinoma of the head and neck (oral, oropharynx, hypopharynx, larynx)
- At least one measurable tumor lesion by imaging (RECIST 1.1 criteria)
- Clinical stage III-IVb (P16-) or II-III (P16+)
- Available tumor samples for gene expression detection
- ECOG performance status score of 0 or 1
- No prior radiotherapy, chemotherapy, or other anti-tumor treatments
- Hematological requirements: neutrophil count ≥ 1.5×10⁹/L; hemoglobin ≥ 10 g/dL; platelet count ≥ 100×10⁹/L
- Biochemical requirements: total bilirubin ≤ 1.5× upper limit of normal (ULN); AST and ALT < 1.5× ULN; creatinine clearance ≥ 60 ml/min; alkaline phosphatase ≤ 5× ULN; APTT and INR ≤ 1.5× ULN (stable anticoagulant therapy allowed)
- Use of effective contraception for participants of childbearing potential
- Signed informed consent
- Ability to follow study protocols and attend follow-up
You will not qualify if you...
- Previous anti-tumor treatment within 6 months including radiotherapy, chemotherapy, surgery, or immunotherapy
- Current or history of other malignant tumors except certain cured cancers (e.g., basal cell carcinoma, cervical carcinoma in situ) with over 5 years survival
- Presence of distant metastasis
- Active or history of autoimmune diseases (except stable hypothyroidism, type 1 diabetes on insulin, vitiligo, or resolved childhood asthma/allergies)
- Known primary immunodeficiency or HIV infection
- Severe infection within 4 weeks before treatment start
- Severe liver or kidney dysfunction, uncontrolled heart disease, uncontrolled diabetes or hypertension
- Untreated chronic hepatitis B or active hepatitis C infection
- History of interstitial lung disease or non-infectious pneumonia
- Active tuberculosis infection or untreated history within 1 year
- Recent use of systemic corticosteroids or immunosuppressants within 2 weeks before study drug
- Vaccination with live vaccines within 4 weeks before study drug
- Major surgery or severe trauma within 4 weeks before study drug
- Participation in another clinical trial simultaneously
- Pregnant or breastfeeding women; negative pregnancy test required for women of childbearing potential
- Substance abuse or psychological/social factors affecting consent or participation
- Known allergy to study drugs
- Inability to undergo radiotherapy or chemotherapy due to social or geographic factors
- Significant weight loss (≥ 10%) within 6 weeks before enrollment
- Any other factors impacting safety or compliance
- Contraindications to hormone use
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Oncology, Drum Tower Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
J
Jing Yan
CONTACT
K
Kongcheng Wang
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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