NCT07145931尚未招募2 期
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
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年9月20日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment group
Experimental
- 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.
干预措施: Neoadjuvant chemoimmunotherapy (Procedure)
Treatment group
Experimental
- 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.
干预措施: Tislelizumab Nab paclitaxel (Drug)
结局指标
主要结局
Objective response rate
时间窗: 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).
次要结局
- R0 Resection Rate(Perioperative)
- Number of participants with Adverse Events(Until 21 days after the end of the study)
- Pathologic Efficacy(Perioperative)
- Clinical Downstaging Rate(Within 3 weeks after completion of neoadjuvant therapy.)
- Surgical Conversion Rate(Within 3 weeks after completion of neoadjuvant therapy.)
- Organ Preservation Rate(Perioperative)
- Recurrence-Free Survival(Until cancer recurrence or death or the last follow-up, whichever came first, assessed up to 24 months)
- Overall Survival(Until death from any cause or the last follow-up, whichever came first, assessed up to 24 months)
研究者
Yujie Liang
MD, DDS, PhD, Associate Professor, Chief Physician
Sun Yat-sen University
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Neoadjuvant Immunochemotherapy for Adenocarcinoma of the Esophagogastric JunctionEsophageal CancerNCT06469060Shanghai Chest Hospital34
尚未招募
不适用
Tislelizumab in Combination With Chemotherapy as a Neoadjuvant Treatment for Advanced Endometrial CancerEndometrial NeoplasmsNCT06363708Zhongnan Hospital20
尚未招募
2 期
Neoajuvant Tislelizumab Combined with Chemotherapy for Initially Unresectable Stage IIIA/N2 Non-small Cell Lung CancerNSCLC, Stage IIIANSCLC (non-small Cell Lung Cancer)NCT06614231Sun Yat-sen University48
招募中
2 期
Pilot Study of PD-1inhibitor (Tislelizumab) Plus Chemotherapy as Neoadjuvant Therapy for Limited-Stage Small-Cell Lung CancerSmall-cell Lung CancerNCT04542369Shanghai Pulmonary Hospital, Shanghai, China15
Unknown
2 期
Neoadjuvant Chemotherapy and Tilelizumab in Stage III（cTNM-IIIA.IIIB）Non-small-cell Lung CancerStage IIINon-small Cell Lung CancerNCT04865705West China Hospital33