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Neoadjuvant Tislelizumab Plus Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer (NeoSPOT)

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ClinicalTrials.gov Identifier: NCT06009861
Recruitment Status : Recruiting
First Posted : August 24, 2023
Last Update Posted : August 24, 2023
Sponsor:
Information provided by (Responsible Party):
Peking University Hospital of Stomatology

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Oral Squamous Cell Carcinoma Oropharyngeal Squamous Cell Carcinoma Drug: Tislelizumab Drug: Albumin-Bound Paclitaxel Drug: Cisplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 27, 2023
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : August 31, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Neoadjuvant Tislelizumab plus chemotherapy and adjuvant RT or Tislelizumab plus CCRT

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.

 Drug: Tislelizumab
Dose: 200 mg Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks

Drug: Albumin-Bound Paclitaxel
Dose: 260 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks

Drug: Cisplatin
Dose: 60-75 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Event free survival (EFS) at 2 years [ Time Frame: Up to 2 years ]
    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.


Secondary Outcome Measures :
  1. Major Pathological Response (mPR) [ Time Frame: Up to 30 days post-surgery ]
    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.

  2. Pathological Complete Response (pCR) [ Time Frame: Up to 30 days post-surgery ]
    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.

  3. Overall response rate (ORR) [ Time Frame: UP to 30 days prior-surgery ]
    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.

  4. Overall survival (OS) [ Time Frame: Up to 2 years ]
    OS is the time from randomization to death due to any cause.

  5. Adverse events (AEs) [ Time Frame: Up to 2 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cytological or histological diagnosis of initially or potentially surgically resectable Local advanced oral/oropharyngeal squamous cell carcinoma (stage III-IV).
  • Plan to proceed neoadjuvant therapy.
  • No prior anti-cancer treatment (include surgery, radiotherapy and systemic therapy) for oral/oropharyngeal squamous cell carcinoma.
  • Clinically evaluable lesions per RECIST1.1.
  • The age of signing the informed consent is 18-80 years old, regardless of gender.
  • ECOG performance score 0-1.
  • Estimated survival time≥6 months (this criterion overlaps with other inclusion criteria and must meet the following: ECOG score 0-1; Vital organ function meets the inclusion criteria in Article 8; Oral or oropharyngeal cancer does not involve the internal carotid artery; No subcutaneous metastases; No distant metastasis).
  • Adequate organ function as follows: 1) Leukocyte count ≥ 3,000/mm3; 2) Absolute neutrophil count ≥ 1,500/mm3; 3) Platelet count ≥ 100,000/mm3; 4) Hemoglobin ≥ 90 g/L; 5) Serum creatinine ≤ 1.5 × ULN OR CrCl≥50 ml/min（Cockcroft-Gault）; 6) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); 7) AST (SGOT) and ALT (SGPT) < 2.5 × ULN;
  • Subjects able and willing to follow research and follow-up procedures.
  • For male and female subjects of childbearing age must agree to use adequate contraception throughout the study period and for 6 months after the end of treatment.
  • Subjects voluntarily joined the clinical study and signed the informed consent.

Exclusion Criteria:

  • Previous therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody targeting T cell co-regulatory pathways.
  • History of allergy, and may have a potential allergy or intolerance to the investigational drug and its similar biologics.
  • Participated in clinical trials of other antitumor drugs within 4 weeks prior to initial administration; Or receive live attenuated vaccine within 4 weeks prior to initial administration or during the study period;
  • Subjects with concurrent other active malignancies. History of other types for cancer within past 5 years (exclude adequately treated skin squamous cell carcinoma or controlled skin basal cell carcinoma).
  • Advanced subjects with symptoms, visceral dissemination, and a short-term risk of life-threatening complications (including uncontrolled massive exudation [pleural, pericardial, peritoneal], pulmonary lymphangitis, and more than 30% liver involvement).
  • Subjects with active autoimmune disease or history of refractory autoimmune disease.
  • Subjects with grade II or higher myocardial ischemia or myocardial infarction, uncontrolled arrhythmia (including QTc interval ≥450 ms in men and ≥470 ms in women), NYHA class III-IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) <50% on echocardiography, myocardial infarction within 6 months before enrollment, New York Heart Association class II or higher heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram suggestive of acute ischemia or active conduction system abnormalities;
  • Severe infection (e.g. requiring intravenous antibiotics, antifungal or antiviral medication) within 4 weeks before first dose, or unexplained fever >38.5°C during screening/before first dose;
  • Subjects with a history of abuse of psychotropic substances and unable to withdraw from them or with mental disorders;
  • Subjects undergone major surgery or have an open wound or fracture within 4 weeks before the first dose;
  • Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection of the analytical method) or co-infection of hepatitis B and hepatitis C;
  • Central nervous system metastasis;
  • Subjects with a history of genetic or acquired bleeding or coagulation dysfunction (eligibility criteria at the investigator's discretion);
  • Other conditions that the investigator determined were inappropriate for participation in the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06009861


Contacts
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Contact: Jie Zhang +86 10 82195246 zhangjie123@bjmu.edu.cn

Locations
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China, Beijing
Peking University School and Hospital Stomatology Recruiting
Beijing, Beijing, China, 100000
Contact: Jie Zhang, Dr.    +86 10 82195382    zhangjie06@126.com   
Sub-Investigator: Wenjie Wu, Dr.         
China, Hebei
Affiliated Hospital of Hebei University Recruiting
Baoding, Hebei, China
Contact: Zhizheng Zhuang, Dr.         
Tangshan People's Hospital Recruiting
Tangshan, Hebei, China
Contact: Chenglin Dai, Dr.         
China, Heilongjiang
The First Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China
Contact: Jichen Li, Dr.         
China, Inner Mongolia
Affiliated Hospital of Chifeng College Recruiting
Chifeng, Inner Mongolia, China
Contact: Pengfei Ma, Dr.         
The Affiliated Hospital of Inner Mongolia Medical University Recruiting
Hohhot, Inner Mongolia, China
Contact: Bateer Delehei, Dr.         
China, Jilin
The Hospital of Stomatology of Jilin University Recruiting
Changchun, Jilin, China
Contact: Qilin Liu, Dr.         
China, Liaoning
China Medical University School and Hospital Of Stomatology Recruiting
Shenyang, Liaoning, China
Contact: Fayu Liu, Dr.         
China, Shandong
Shandong Provincial Hospital Recruiting
Jinan, Shandong, China
Contact: Shizhou Zhang, Dr.         
Shandong Provincial Hospital Recruiting
Jinan, Shandong, China
Contact: Weidong Zhang, Dr.         
The Affiliated Hospital of Qingdao University Recruiting
Qingdao, Shandong, China
Contact: Wei Shang, Dr.         
China, Shanxi
First Hospital of Shanxi Medical University Recruiting
Taiyuan, Shanxi, China
Contact: Xinrong Nan, Dr.         
Shanxi Cancer hospital Recruiting
Taiyuan, Shanxi, China
Contact: Fei Han, Dr.         
China, Tianjin
Tianjin First Central Hospital Recruiting
Tianjin, Tianjin, China
Contact: Yongdong Zhang, Dr.         
Sponsors and Collaborators
Peking University Hospital of Stomatology
More Information
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Responsible Party: Peking University Hospital of Stomatology
ClinicalTrials.gov Identifier: NCT06009861    
Other Study ID Numbers: PKUSSIRB-202386047
First Posted: August 24, 2023    Key Record Dates
Last Update Posted: August 24, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Paclitaxel
 Tislelizumab
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological