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Trial Title:
Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma ：A Single-arm, Prospective, Phase II Trial
NCT ID:
NCT05862168
Condition:
Oral Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Paclitaxel
Fluorouracil
Tislelizumab
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:
The participants will receive 3 cycles of Tislelizumab, with 21 days each. 200mg of
Tislelizumab will be used intravenously on the first day of each cycle.
Arm group label:
Treatment
Intervention type:
Drug
Intervention name:
Albumin paclitaxel
Description:
The participants will receive 3 cycles of Albumin paclitaxel, with 21 days each.
200mg/m^2 of Albumin paclitaxel will be used intravenously on the first day of each
cycle.
Arm group label:
Treatment
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
The participants will receive 3 cycles of Cisplatin, with 21 days each. 20mg/m^2 of
Cisplatin will be used intravenously on days 1 through 3 of each cycle.
Arm group label:
Treatment
Intervention type:
Drug
Intervention name:
5-Fluorouracil
Description:
The participants will receive 3 cycles of 5-Fluorouracil, with 21 days each. 600mg/m^2/d
of 5-Fluorouracil will be used as a 120-hour continuous intravenous infusion on days 1
through 5.
Arm group label:
Treatment
Summary:
TPF is still recommended as the preferred induction chemotherapy regimen for nonsurgical
treatment of patients with LA HNSCC. Based on the KEYNOTE-048 study, all major guidelines
recommend PD-1 monotherapy or PD-1 combined with chemotherapy as the new first-line
standard treatment for patients with advanced HNSCC. The immunotherapy in operable LA
HNSCC was also explored as neoadjuvant therapy due to the excellent data in advanced
HNSCC. These explorations have also achieved good results. Therefore, this study aims to
explore the pathological remission rate, the long-term benefit and safety of Tislelizumab
combined with albumin paclitaxel, cisplatin and fluorouracil for locally advanced oral
squamous cell carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed the informed consent form
2. Histopathological diagnosis of oral squamous cell carcinoma
3. Age: 18-75 years old , Gender: male and female
4. Primary tumor with a clinical stage of III/IVb (T1-2N+M0或T3-4N0-3M0, AJCC2018)
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
6. No previous systematic therapy for OSCC (including chemotherapy, EGFR inhibitors,
VEGFR inhibitors such as bevacizumab, immune checkpoint inhibition such as anti-PD-1
or PD-L1 antibodies, anti-ctLA-4 antibodies, etc.);
7. Patients must have at least one measurable lesion according to the Response
Evaluation Criteria in Solid Tumors (RECIST v1.1)
8. Adequte organ function based on laboratory test values obtained during the screening
period：1）Blood routine: white blood cells (WBCs) >3.0× 109/L, ANC >1.5× 109/L,
platelets >75× 109/L, hemoglobin >9 g/L, 2）Liver function: alanine amino
transferase/aspartate amino transferase (ALAT/ASAT) <2.5 times the upper limit of
normal and bilirubin <1.5 times the upper limit of normal，3）Renal function: Serum
creatinine <1.5 times the upper limit of normal，4）Coagulation function: INR, PT,
APTT<1.5 times the upper limit of normal，5）Left ventricular ejection fraction (LVEF)
≥ 50%
9. contraception
Exclusion Criteria:
1. Known history of malignancy, unless been cured and no recurrence for 5 years
2. Patients with a history of active bleeding, coagulopathy, or receiving coumarin
anticoagulation therapy
3. Known history of radiation, chemotherapy, surgery and immunology-based treatment to
head and neck
4. Active autoimmune disease requiring systemic treatment within 2 years prior to the
first dose, or autoimmune disease that may recur or plan treatment as judged by the
investigator.
5. Active or previous definite inflammatory bowel disease (e.g., Crohn 's disease or
ulcerative colitis) disease.
6. Subjects with known active pulmonary tuberculosis (TB) and suspected active TB
require clinical examination to rule out; known active syphilis infection.
7. Serious infections within 4 weeks prior to the first dose, including but not limited
to comorbidities requiring hospitalization, sepsis, or serious pneumonia; active
infections (excluding antiviral therapy for hepatitis B or C) that have received
systemic anti-infective therapy within 2 weeks prior to the first dose.
8. Known human immunodeficiency virus (HIV) infection
9. Subjects with untreated active hepatitis B (HBsAg positive and HBV-DNA more than
1000 copies/ml [200 IU/ml] or above the lower limit of detection) and anti-hepatitis
B virus treatment during study treatment are required for subjects with hepatitis B;
subjects with active hepatitis C (HCV antibody positive and HCV-RNA level above the
lower limit of detection).
10. History of pneumonitis/interstitial lung disease requiring systemic corticosteroids
or current pneumonitis.
11. Known allergic reaction to any ingredients or excipients of the therapy
12. Participation in other clinical trials within 30 days before enrollment
13. Pregnant or lactating women
14. Known alle Other situations that the investigator considers unsuitable with respect
to participating in the trial
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First affiliated hospital, School of Medicine, Zhejiang University
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Weijia Fang, Doctor
Start date:
May 8, 2023
Completion date:
June 30, 2028
Lead sponsor:
Agency:
Weijia Fang, MD
Agency class:
Other
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05862168
