xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06009861</url>
    </required_header>
    <id_info>
      <org_study_id>PKUSSIRB-202386047</org_study_id>
      <nct_id>NCT06009861</nct_id>
    </id_info>
    <brief_title>Neoadjuvant Tislelizumab Plus Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer (NeoSPOT)</brief_title>
    <official_title>Neoadjuvant Chemoimmunotherapy With Tislelizumab, Albumin-bound Paclitaxel, and Cisplatin in Locally Advanced Oral/Oropharyngeal Squamous Cell Carcinoma: A Prospective, Multicenter, Single-arm Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University Hospital of Stomatology</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University Hospital of Stomatology</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Previous studies confirmed locally advanced oral/oropharyngeal squamous cell carcinoma (LA&#xD;
        OSCC or OPSCC) patients with a pathological response had higher probability of survival in&#xD;
        neoadjuvant settings. Several ongoing trials of neoadjuvant immunotherapy in head and neck&#xD;
        cancer showed promising results. However, the optimal regimen remains unclear. This trial&#xD;
        aimed to evaluate the efficacy and safety of neoadjuvant therapy with anti-programmed cell&#xD;
        death 1 monoclonal antibody Tislelizumab and chemotherapy, followed by surgery and adjuvant&#xD;
        radiotherapy or chemoradiotherapy plus Tislelizumab in LA OSCC or OPSCC.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 27, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of Event free survival (EFS) at 2 years</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>EFS is the time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence as assessed with imaging or biopsy as indicated; or death due to any cause.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Major Pathological Response (mPR)</measure>
      <time_frame>Up to 30 days post-surgery</time_frame>
      <description>The proportion of participants with a major pathological response (mPR) as assessed by the Central Pathologist at the time of definitive surgery. mPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pathological Complete Response (pCR)</measure>
      <time_frame>Up to 30 days post-surgery</time_frame>
      <description>Pathological complete response (pCR) is measured as the proportion of participants with a pathological complete response as assessed by the central pathologist at the time of definitive surgery. pCR is defined as having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall response rate (ORR)</measure>
      <time_frame>UP to 30 days prior-surgery</time_frame>
      <description>Overall response rate (ORR) is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>OS is the time from randomization to death due to any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events (AEs)</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Number of participants experiencing any sign, symptom, disease, or worsening of preexisting conditions temporally associated with the experimental interventions or irrespective of the experimental interventions per NCI-CTCAE V5.0.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">110</enrollment>
    <condition>Oral Squamous Cell Carcinoma</condition>
    <condition>Oropharyngeal Squamous Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>Neoadjuvant Tislelizumab plus chemotherapy and adjuvant RT or Tislelizumab plus CCRT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Neoadjuvant phase: Patients will receive neoadjuvant Tislelizumab in combination with Albumin-Bound Paclitaxel and Cisplatin Q3W for 2 cycles.&#xD;
  Adjuvant phase:&#xD;
  For High-risk group(non-R0 resection or extranodal extension (ENE) or Lymph node metastasis&gt;5): Concurrent chemoradiotherapy followed by Tislelizumab Q3W for 14 cycles.&#xD;
  For the other group: intensity-modulated radiation therapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tislelizumab</intervention_name>
      <description>Dose: 200 mg Route: Intravenous infusion Frequency &amp; treatment mode: Day 1, every 3 weeks</description>
      <arm_group_label>Neoadjuvant Tislelizumab plus chemotherapy and adjuvant RT or Tislelizumab plus CCRT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Albumin-Bound Paclitaxel</intervention_name>
      <description>Dose: 260 mg/m^2 Route: Intravenous infusion Frequency &amp; treatment mode: Day 1, every 3 weeks</description>
      <arm_group_label>Neoadjuvant Tislelizumab plus chemotherapy and adjuvant RT or Tislelizumab plus CCRT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cisplatin</intervention_name>
      <description>Dose: 60-75 mg/m^2 Route: Intravenous infusion Frequency &amp; treatment mode: Day 1, every 3 weeks</description>
      <arm_group_label>Neoadjuvant Tislelizumab plus chemotherapy and adjuvant RT or Tislelizumab plus CCRT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Cytological or histological diagnosis of initially or potentially surgically&#xD;
               resectable Local advanced oral/oropharyngeal squamous cell carcinoma (stage III-IV).&#xD;
  &#xD;
            -  Plan to proceed neoadjuvant therapy.&#xD;
  &#xD;
            -  No prior anti-cancer treatment (include surgery, radiotherapy and systemic therapy)&#xD;
               for oral/oropharyngeal squamous cell carcinoma.&#xD;
  &#xD;
            -  Clinically evaluable lesions per RECIST1.1.&#xD;
  &#xD;
            -  The age of signing the informed consent is 18-80 years old, regardless of gender.&#xD;
  &#xD;
            -  ECOG performance score 0-1.&#xD;
  &#xD;
            -  Estimated survival time≥6 months (this criterion overlaps with other inclusion&#xD;
               criteria and must meet the following: ECOG score 0-1; Vital organ function meets the&#xD;
               inclusion criteria in Article 8; Oral or oropharyngeal cancer does not involve the&#xD;
               internal carotid artery; No subcutaneous metastases; No distant metastasis).&#xD;
  &#xD;
            -  Adequate organ function as follows: 1) Leukocyte count ≥ 3,000/mm3; 2) Absolute&#xD;
               neutrophil count ≥ 1,500/mm3; 3) Platelet count ≥ 100,000/mm3; 4) Hemoglobin ≥ 90 g/L;&#xD;
               5) Serum creatinine ≤ 1.5 × ULN OR CrCl≥50 ml/min（Cockcroft-Gault）; 6) Total bilirubin&#xD;
               ≤ 1.5 × upper limit of normal (ULN); 7) AST (SGOT) and ALT (SGPT) &lt; 2.5 × ULN;&#xD;
  &#xD;
            -  Subjects able and willing to follow research and follow-up procedures.&#xD;
  &#xD;
            -  For male and female subjects of childbearing age must agree to use adequate&#xD;
               contraception throughout the study period and for 6 months after the end of treatment.&#xD;
  &#xD;
            -  Subjects voluntarily joined the clinical study and signed the informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other&#xD;
               antibody targeting T cell co-regulatory pathways.&#xD;
  &#xD;
            -  History of allergy, and may have a potential allergy or intolerance to the&#xD;
               investigational drug and its similar biologics.&#xD;
  &#xD;
            -  Participated in clinical trials of other antitumor drugs within 4 weeks prior to&#xD;
               initial administration; Or receive live attenuated vaccine within 4 weeks prior to&#xD;
               initial administration or during the study period;&#xD;
  &#xD;
            -  Subjects with concurrent other active malignancies. History of other types for cancer&#xD;
               within past 5 years (exclude adequately treated skin squamous cell carcinoma or&#xD;
               controlled skin basal cell carcinoma).&#xD;
  &#xD;
            -  Advanced subjects with symptoms, visceral dissemination, and a short-term risk of&#xD;
               life-threatening complications (including uncontrolled massive exudation [pleural,&#xD;
               pericardial, peritoneal], pulmonary lymphangitis, and more than 30% liver&#xD;
               involvement).&#xD;
  &#xD;
            -  Subjects with active autoimmune disease or history of refractory autoimmune disease.&#xD;
  &#xD;
            -  Subjects with grade II or higher myocardial ischemia or myocardial infarction,&#xD;
               uncontrolled arrhythmia (including QTc interval ≥450 ms in men and ≥470 ms in women),&#xD;
               NYHA class III-IV cardiac insufficiency, or left ventricular ejection fraction (LVEF)&#xD;
               &lt;50% on echocardiography, myocardial infarction within 6 months before enrollment, New&#xD;
               York Heart Association class II or higher heart failure, uncontrolled angina,&#xD;
               uncontrolled severe ventricular arrhythmia, clinically significant pericardial&#xD;
               disease, or electrocardiogram suggestive of acute ischemia or active conduction system&#xD;
               abnormalities;&#xD;
  &#xD;
            -  Severe infection (e.g. requiring intravenous antibiotics, antifungal or antiviral&#xD;
               medication) within 4 weeks before first dose, or unexplained fever &gt;38.5°C during&#xD;
               screening/before first dose;&#xD;
  &#xD;
            -  Subjects with a history of abuse of psychotropic substances and unable to withdraw&#xD;
               from them or with mental disorders;&#xD;
  &#xD;
            -  Subjects undergone major surgery or have an open wound or fracture within 4 weeks&#xD;
               before the first dose;&#xD;
  &#xD;
            -  Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency&#xD;
               syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive&#xD;
               hepatitis C antibody and HCV-RNA above the lower limit of detection of the analytical&#xD;
               method) or co-infection of hepatitis B and hepatitis C;&#xD;
  &#xD;
            -  Central nervous system metastasis;&#xD;
  &#xD;
            -  Subjects with a history of genetic or acquired bleeding or coagulation dysfunction&#xD;
               (eligibility criteria at the investigator's discretion);&#xD;
  &#xD;
            -  Other conditions that the investigator determined were inappropriate for participation&#xD;
               in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jie Zhang</last_name>
      <phone>+86 10 82195246</phone>
      <email>zhangjie123@bjmu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peking University School and Hospital Stomatology</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jie Zhang, Dr.</last_name>
        <phone>+86 10 82195382</phone>
        <email>zhangjie06@126.com</email>
      </contact>
      <investigator>
        <last_name>Wenjie Wu, Dr.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Affiliated Hospital of Hebei University</name>
        <address>
          <city>Baoding</city>
          <state>Hebei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zhizheng Zhuang, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tangshan People's Hospital</name>
        <address>
          <city>Tangshan</city>
          <state>Hebei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chenglin Dai, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Harbin Medical University</name>
        <address>
          <city>Harbin</city>
          <state>Heilongjiang</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jichen Li, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Affiliated Hospital of Chifeng College</name>
        <address>
          <city>Chifeng</city>
          <state>Inner Mongolia</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Pengfei Ma, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Affiliated Hospital of Inner Mongolia Medical University</name>
        <address>
          <city>Hohhot</city>
          <state>Inner Mongolia</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bateer Delehei, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Hospital of Stomatology of Jilin University</name>
        <address>
          <city>Changchun</city>
          <state>Jilin</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Qilin Liu, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>China Medical University School and Hospital Of Stomatology</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fayu Liu, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shandong Provincial Hospital</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shizhou Zhang, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shandong Provincial Hospital</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Weidong Zhang, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Affiliated Hospital of Qingdao University</name>
        <address>
          <city>Qingdao</city>
          <state>Shandong</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wei Shang, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>First Hospital of Shanxi Medical University</name>
        <address>
          <city>Taiyuan</city>
          <state>Shanxi</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xinrong Nan, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shanxi Cancer hospital</name>
        <address>
          <city>Taiyuan</city>
          <state>Shanxi</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fei Han, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tianjin First Central Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yongdong Zhang, Dr.</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Squamous Cell</mesh_term>
      <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Paclitaxel</mesh_term>
      <mesh_term>Tislelizumab</mesh_term>
      <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06009861
  org study id: PKUSSIRB-202386047
  nct id: NCT06009861
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Previous studies confirmed locally advanced oral/oropharyngeal squamous cell carcinoma (LA
        OSCC or OPSCC) patients with a pathological response had higher probability of survival in
        neoadjuvant settings. Several ongoing trials of neoadjuvant immunotherapy in head and neck
        cancer showed promising results. However, the optimal regimen remains unclear. This trial
        aimed to evaluate the efficacy and safety of neoadjuvant therapy with anti-programmed cell
        death 1 monoclonal antibody Tislelizumab and chemotherapy, followed by surgery and adjuvant
        radiotherapy or chemoradiotherapy plus Tislelizumab in LA OSCC or OPSCC.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Rate of Event free survival (EFS) at 2 years
  time frame: Up to 2 years
  description: EFS is the time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence as assessed with imaging or biopsy as indicated; or death due to any cause.
  measure: Major Pathological Response (mPR)
  time frame: Up to 30 days post-surgery
  description: The proportion of participants with a major pathological response (mPR) as assessed by the Central Pathologist at the time of definitive surgery. mPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.
  measure: Pathological Complete Response (pCR)
  time frame: Up to 30 days post-surgery
  description: Pathological complete response (pCR) is measured as the proportion of participants with a pathological complete response as assessed by the central pathologist at the time of definitive surgery. pCR is defined as having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes.
  measure: Overall response rate (ORR)
  time frame: UP to 30 days prior-surgery
  description: Overall response rate (ORR) is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.
  measure: Overall survival (OS)
  time frame: Up to 2 years
  description: OS is the time from randomization to death due to any cause.
  measure: Adverse events (AEs)
  time frame: Up to 2 years
  description: Number of participants experiencing any sign, symptom, disease, or worsening of preexisting conditions temporally associated with the experimental interventions or irrespective of the experimental interventions per NCI-CTCAE V5.0.
  arm group label: Neoadjuvant Tislelizumab plus chemotherapy and adjuvant RT or Tislelizumab plus CCRT
  arm group type: Experimental
  description: Neoadjuvant phase: Patients will receive neoadjuvant Tislelizumab in combination with Albumin-Bound Paclitaxel and Cisplatin Q3W for 2 cycles.
  Adjuvant phase:
  For High-risk group(non-R0 resection or extranodal extension (ENE) or Lymph node metastasis>5): Concurrent chemoradiotherapy followed by Tislelizumab Q3W for 14 cycles.
  For the other group: intensity-modulated radiation therapy.
  intervention type: Drug
  intervention name: Tislelizumab
  description: Dose: 200 mg Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks
  arm group label: Neoadjuvant Tislelizumab plus chemotherapy and adjuvant RT or Tislelizumab plus CCRT
  intervention type: Drug
  intervention name: Albumin-Bound Paclitaxel
  description: Dose: 260 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks
  arm group label: Neoadjuvant Tislelizumab plus chemotherapy and adjuvant RT or Tislelizumab plus CCRT
  intervention type: Drug
  intervention name: Cisplatin
  description: Dose: 60-75 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks
  arm group label: Neoadjuvant Tislelizumab plus chemotherapy and adjuvant RT or Tislelizumab plus CCRT
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Jie Zhang
  phone: +86 10 82195246
  email: zhangjie123@bjmu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Squamous Cell Carcinoma of Head and Neck
  mesh term: Paclitaxel
  mesh term: Tislelizumab
  mesh term: Albumin-Bound Paclitaxel
  sharing ipd: No