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

NCT06009861 | Active Not Recruiting Phase 2

• 1 other identifier: PKUSSIRB-202386047
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 13

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.

Conditions

Oral Squamous Cell Carcinoma; Oropharyngeal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Rate of Event free survival (EFS) at 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.

  Up to 2 years

Secondary Outcomes (5)

• Major Pathological Response (mPR)

  Up to 30 days post-surgery

• Pathological Complete Response (pCR)

  Up to 30 days post-surgery

• Overall response rate (ORR)

  UP to 30 days prior-surgery

• Overall survival (OS)

  Up to 2 years

• Adverse events (AEs)

  Up to 2 years

Study Arms (1)

Neoadjuvant Tislelizumab plus chemotherapy and adjuvant RT or Tislelizumab plus CCRT

EXPERIMENTAL

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; Drug: Albumin-Bound Paclitaxel; Drug: Cisplatin

Interventions

Tislelizumab DRUG

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

Neoadjuvant Tislelizumab plus chemotherapy and adjuvant RT or Tislelizumab plus CCRT

Albumin-Bound Paclitaxel DRUG

Dose: 260 mg/m\^2 Route: Intravenous infusion Frequency \& treatment mode: Day 1, every 3 weeks

Neoadjuvant Tislelizumab plus chemotherapy and adjuvant RT or Tislelizumab plus CCRT

Cisplatin DRUG

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

Neoadjuvant Tislelizumab plus chemotherapy and adjuvant RT or Tislelizumab plus CCRT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Hospital of Stomatology: lead

Study Sites (13)

Peking University School and Hospital Stomatology

Beijing, Beijing Municipality, 100000, China

Location

Affiliated Hospital of Hebei University

Baoding, Hebei, China

Location

Tangshan People's Hospital

Tangshan, Hebei, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

Affiliated Hospital of Chifeng College

Chifeng, Inner Mongolia, China

Location

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Location

The Hospital of Stomatology of Jilin University

Changchun, Jilin, China

Location

China Medical University School and Hospital Of Stomatology

Shenyang, Liaoning, China

Location

Shandong Provincial Hospital

Jinan, Shandong, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Shanxi Cancer hospital

Taiyuan, Shanxi, China

Location

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

tislelizumab; Albumin-Bound Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 24, 2023
• Study Start: June 27, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)