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NCT Number: NCT07145931

Neoadjuvant Immunochemotherapy and Postoperative Adjuvant Immunotherapy for Head and Neck Squamous Cell Carcinoma Invading the Skull Base

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 immunotherapy in patients with skull base-invading head and neck squamous cell carcinoma. The primary objectives are to address the following questions:

* What are the objective response rate and pathological response of tislelizumab combined with chemotherapy as neoadjuvant therapy in patients with skull base-invading head and neck squamous cell carcinoma? * Can neoadjuvant therapy convert unresectable skull base-invading head and neck squamous cell carcinoma into a resectable condition? * Can adjuvant immunotherapy after neoadjuvant therapy prolong patients' recurrence-free survival and overall survival? The researchers will administer neoadjuvant therapy (tislelizumab combined with chemotherapy) and adjuvant immunotherapy to patients with skull base-invading head and neck squamous cell carcinoma and assess the treatment's efficacy and safety.

Participants will:

* Receive neoadjuvant therapy every 3 weeks (tislelizumab 200mg on Day 1, nab-paclitaxel 260mg/m² on Day 1, cisplatin 75mg/m² on Days 1-3) for 3 cycles. * Undergo surgical treatment within 3 weeks after completing neoadjuvant therapy. * Receive (chemo)radiotherapy 4-6 weeks after surgery. * Receive adjuvant immunotherapy (tislelizumab 200mg) every 3 weeks after (chemo)radiotherapy for 8 cycles.

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Key information

Conditions

Head and Neck Cancer Squamous Cell Carcinoma Neoadjuvant Chemoimmunotherapy Objective Response Rate Skull Base--Cancer

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Neoadjuvant chemoimmunotherapy

Procedure
  • Neoadjuvant therapy is administered every 3 weeks (Tislelizumab 200mg D1, Nab Paclitaxel 260mg/m² D1, Cisplatin 75mg/m² D1-3) for a total of 3 cycles.
  • Surgical treatment is performed within 3 weeks after completing neoadjuvant therapy.
  • Postoperative (chemo)radiotherapy is initiated 4-6 weeks after surgery.
  • Following (chemo)radiotherapy, adjuvant immunotherapy (Tislelizumab 200mg) is administered every 3 weeks for a total of 8 cycles.

Other names: Surgery, Adjuvant immunotherapy

Tislelizumab Nab paclitaxel

Drug

Neoadjuvant therapy is administered every 3 weeks (Tislelizumab 200mg D1, Nab Paclitaxel 260mg/m² D1, Cisplatin 75mg/m² D1-3) for a total of 3 cycles.

Other names: Cisplatin

Primary outcomes

  1. Objective response rate

    Time frame: Within 3 weeks after completion of neoadjuvant therapy

    Objective Response Rate (ORR) is a pivotal efficacy endpoint in oncology therapeutic evaluation, defined as the proportion of patients whose tumor burden shrinks to a prespecified threshold (achieving either complete or partial response). This metric is measured using internationally standardized criteria (RECIST 1.1), with radiographic imaging to monitor changes in the sum of target lesion diameters. Based on Standardized Criteria (e.g., RECIST 1.1). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥30% decrease in tumor size (sum of target lesions). ORR = CR + PR (expressed as a percentage).

Secondary outcomes

  1. Number of participants with Adverse Events

    Time frame: Until 21 days after the end of the study

    To evaluate the adverse events during the study period according to the NCI-CTCAE, version 5.0, including vital signs, physical examination, laboratory tests, changes in ECOG score, etc., as well as adverse events and serious adverse events, are calculated to the incidence of adverse events and serious adverse events.

  2. Pathologic Efficacy

    Time frame: Perioperative

    The percentage of residual tumor cells in tumor bed of pathological specimens after surgery. Pathological complete response (pCR) refers to tumors the absence of any viable tumor cells within the tumor bed. Major pathological response (MPR) is defined as 10% or fewer residual viable tumor cells within the tumor bed.

  3. Clinical Downstaging Rate

    Time frame: Within 3 weeks after completion of neoadjuvant therapy.

    The proportion of patients with reduction in clinical TNM stage.

  4. Surgical Conversion Rate

    Time frame: Within 3 weeks after completion of neoadjuvant therapy.

    The proportion of patients with initially unresectable tumors that become resectable after treatment.

  5. R0 Resection Rate

    Time frame: Perioperative

    The proportion of patients achieving complete tumor removal with microscopically negative margins (no residual tumor cells).

  6. Organ Preservation Rate

    Time frame: Perioperative

    The proportion of patients who, despite pretreatment tumor invasion into critical organs (e.g., eyeball, internal carotid artery, dura mater), successfully retain the involved organ while still achieving R0 resection.

  7. Recurrence-Free Survival

    Time frame: Until cancer recurrence or death or the last follow-up, whichever came first, assessed up to 24 months

    The time from enrollment until cancer recurrence or death from any cause.

  8. Overall Survival

    Time frame: Until death from any cause or the last follow-up, whichever came first, assessed up to 24 months

    The time from enrollment until death from any cause or the last follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Yujie Liang

CONTACT

[email protected]

+86 13242879610

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Tislelizumab Combined With Chemotherapy for Neoadjuvant Immunochemotherapy and Postoperative Adjuvant Therapy for Head and Neck Squamous Cell Carcinoma Invading the Skull Base: A Prospective, Single-arm, Phase II Clinical Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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