Actively Recruiting
A Prospective Single-center, Single-arm Clinical Study of the PD-1 Inhibitor Tislelizumab Combined With APF Sequential Surgery or Radical Concurrent Chemoradiotherapy 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
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of tislelizumab combined with APF sequential surgery or radical concurrent chemoradiotherapy to treat locally advanced head and neck tumors. This Phase 2 study aims to assess the treatment's effectiveness and safety, as well as explore genes related to the immune environment that may affect outcomes. The trial focuses on patients with specific stages and types of head and neck squamous cell carcinoma. Participants will receive tislelizumab along with chemotherapy drugs including paclitaxel (albumin-bound type), cisplatin, and 5-FU. Treatment cycles last 21 days, and interventions are given either before surgery or alongside chemoradiotherapy. The study is conducted at a single center and has one study arm receiving this combined immunotherapy and chemotherapy approach. During the trial, participants will undergo evaluations of tumor size and pathological changes after three cycles of treatment. Safety assessments occur at the same intervals to monitor any side effects. Participants must meet specific health criteria before joining and will be monitored for treatment response and adverse events throughout the study, which started in April 2022 and is expected to complete in December 2025.
CONDITIONS
Brief 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 18-75 years old
- Histological or cytology-confirmed squamous cell carcinoma of the head and neck (oral, oropharynx, hypopharynx, larynx)
- At least one measurable lesion by imaging (RECIST 1.1 criteria)
- Clinical stage III-IVb (P16-) or II-III (P16+)
- Availability of tumor samples for gene expression detection
- ECOG performance status of 0-1
- No prior radiotherapy, chemotherapy, or anti-tumor drug treatment
- Hematological counts meeting specified thresholds: neutrophils ≥ 1.5×10⁹/L, hemoglobin ≥ 10 g/dL, platelets ≥ 100×10⁹/L
- Biochemical values within defined limits: total bilirubin ≤1.5×ULN; AST and ALT <1.5×ULN; creatinine clearance ≥60 ml/min; alkaline phosphatase ≤5×ULN; coagulation parameters within expected ranges
- Use of effective contraception for participants of childbearing potential
- Signed informed consent
- Ability to comply with study protocol and follow-up procedures
You will not qualify if you...
- Anti-tumor treatment (radiotherapy, chemotherapy, surgery, immunotherapy) within past 6 months
- Other active malignancies except certain cured cancers over 5 years without recurrence
- Presence of distant metastasis
- Active or history of autoimmune diseases except stable autoimmune hypothyroidism, type 1 diabetes on stable insulin, vitiligo, or resolved childhood allergies/asthma
- Known primary immunodeficiency including HIV or history of organ/bone marrow transplantation
- Severe infection within 4 weeks before study drug administration
- Severe liver, kidney, heart dysfunction or uncontrolled diseases
- Untreated or active hepatitis B or C infections beyond defined thresholds
- History of interstitial lung disease or non-infectious pneumonia
- Active or recent tuberculosis infection
- Use of systemic corticosteroids (>10 mg prednisone equivalent) or immunosuppressants within 2 weeks prior, recent vaccination or major surgery
- Pregnant or lactating women; negative pregnancy test required for women of childbearing age
- Substance abuse or psychological factors impairing consent
- Allergies to study drugs
- Inability to perform radiotherapy or chemotherapy due to social or geographic reasons
- Significant recent weight loss (≥10% in 6 weeks)
- Any factors potentially affecting safety or study compliance
- Contraindications to hormone use
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 - Up to 3 cycles of 21 days each
Participants receive immunotherapy combined with chemotherapy involving Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, and 5-FU.
Visits at the start of each 21-day cycle (3 visits total)
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
K
Kongcheng Wang
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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