Status:
NOT_YET_RECRUITING
Neoadjuvant Immunochemotherapy and Postoperative Adjuvant Immunotherapy for Head and Neck Squamous Cell Carcinoma Invading the Skull Base
Lead Sponsor:
Sun Yat-sen University
Conditions:
Head and Neck Cancer Squamous Cell Carcinoma
Skull Base--Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This prospective, single-arm, Phase II clinical trial aims to evaluate the efficacy and safety of tislelizumab combined with chemotherapy as neoadjuvant therapy and postoperative adjuvant immunotherap...
Eligibility Criteria
Inclusion
- Age 18 to 80 years, regardless of gender;
- Histologically confirmed squamous cell carcinoma (including gingiva, buccal mucosa, palate, oropharynx, maxillary sinus, or maxilla/mandible) with radiological evidence of skull base invasion;
- Measurable tumor lesions (meeting RECIST v1.1 criteria);
- Treatment-naïve primary T4b-stage patients (N any, per AJCC 8th Edition, 2017);
- ECOG PS score: 0-1;
- Medically fit for surgery and chemotherapy, with no surgical contraindications;
- Women of childbearing potential (18-49 years) must have a negative pregnancy test within 7 days before treatment. Sexually active men and women must agree to use effective contraception during the trial and for 3 months after treatment cessation;
- Willing to provide written informed consent and comply with scheduled follow-ups, treatments, lab tests, and other study requirements.
Exclusion
- Previous anti-tumor treatments including chemotherapy, radiotherapy, or immunotherapy; Refusal to sign informed consent;
- Patients who refuse the study treatment protocol; patients unable to complete treatment as planned; or patients unable to comply with regular follow-up due to psychological, social, familial or geographical reasons;
- Patients with known allergies to any study medications;
- Patients with poor systemic conditions unfit for treatment: as determined by routine tests (complete blood count, blood biochemistry, ECG, chest X-ray, etc.). Poor systemic conditions include: hemoglobin \<60g/L, WBC \<3.0×10⁹/L, platelets \<80×10⁹/L, or serum creatinine \>133μmol/L - such patients may be recommended for conservative treatment;
- Patients with autoimmune diseases requiring long-term immunosuppressive or corticosteroid therapy;
- Pregnant or lactating women (pregnancy testing should be considered for sexually active women of childbearing potential);
- Patients with current or previous malignancies (except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or papillary thyroid carcinoma);
- Participation in other clinical trials within 30 days prior to enrollment;
- Other conditions that may compromise patient safety or compliance as assessed by investigators, including: severe comorbidities (including psychiatric disorders), significantly abnormal laboratory results, or other high-risk familial/social factors.
Key Trial Info
Start Date :
September 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 20 2029
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07145931
Start Date
September 20 2025
End Date
September 20 2029
Last Update
August 28 2025
Active Locations (1)
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1
Hospital of Stomatology, Sun Yat-sen University
Guangzhou, Guangdong, China, 510055