Trial Title:
Neoadjuvant Tislelizumab Plus Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer (NeoSPOT)
NCT ID:
NCT06009861
Condition:
Oral Squamous Cell Carcinoma
Oropharyngeal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Paclitaxel
Tislelizumab
Albumin-Bound Paclitaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
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
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University School and Hospital Stomatology
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Zhang, Dr.
Phone:
+86 10 82195382
Email:
zhangjie06@126.com
Investigator:
Last name:
Wenjie Wu, Dr.
Email:
Sub-Investigator
Facility:
Name:
Affiliated Hospital of Hebei University
Address:
City:
Baoding
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhizheng Zhuang, Dr.
Facility:
Name:
Tangshan People's Hospital
Address:
City:
Tangshan
Country:
China
Status:
Recruiting
Contact:
Last name:
Chenglin Dai, Dr.
Facility:
Name:
The First Affiliated Hospital of Harbin Medical University
Address:
City:
Harbin
Country:
China
Status:
Recruiting
Contact:
Last name:
Jichen Li, Dr.
Facility:
Name:
Affiliated Hospital of Chifeng College
Address:
City:
Chifeng
Country:
China
Status:
Recruiting
Contact:
Last name:
Pengfei Ma, Dr.
Facility:
Name:
The Affiliated Hospital of Inner Mongolia Medical University
Address:
City:
Hohhot
Country:
China
Status:
Recruiting
Contact:
Last name:
Bateer Delehei, Dr.
Facility:
Name:
The Hospital of Stomatology of Jilin University
Address:
City:
Changchun
Country:
China
Status:
Recruiting
Contact:
Last name:
Qilin Liu, Dr.
Facility:
Name:
China Medical University School and Hospital Of Stomatology
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Fayu Liu, Dr.
Facility:
Name:
Shandong Provincial Hospital
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Shizhou Zhang, Dr.
Facility:
Name:
Shandong Provincial Hospital
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Weidong Zhang, Dr.
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Shang, Dr.
Facility:
Name:
First Hospital of Shanxi Medical University
Address:
City:
Taiyuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Xinrong Nan, Dr.
Facility:
Name:
Shanxi Cancer hospital
Address:
City:
Taiyuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Fei Han, Dr.
Facility:
Name:
Tianjin First Central Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongdong Zhang, Dr.
Start date:
June 27, 2023
Completion date:
August 31, 2027
Lead sponsor:
Agency:
Peking University Hospital of Stomatology
Agency class:
Other
Source:
Peking University Hospital of Stomatology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06009861
