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Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma :A Single-arm, Prospective, Phase II Trial

Primary Purpose

Oral Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Albumin paclitaxel
Cisplatin
5-Fluorouracil
Sponsored by
Weijia Fang, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed the informed consent form Histopathological diagnosis of oral squamous cell carcinoma Age: 18-75 years old , Gender: male and female Primary tumor with a clinical stage of III/IVb (T1-2N+M0或T3-4N0-3M0, AJCC2018) Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1 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.); Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) 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% contraception Exclusion Criteria: Known history of malignancy, unless been cured and no recurrence for 5 years Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy Known history of radiation, chemotherapy, surgery and immunology-based treatment to head and neck 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. Active or previous definite inflammatory bowel disease (e.g., Crohn 's disease or ulcerative colitis) disease. Subjects with known active pulmonary tuberculosis (TB) and suspected active TB require clinical examination to rule out; known active syphilis infection. 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. Known human immunodeficiency virus (HIV) infection 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). History of pneumonitis/interstitial lung disease requiring systemic corticosteroids or current pneumonitis. Known allergic reaction to any ingredients or excipients of the therapy Participation in other clinical trials within 30 days before enrollment Pregnant or lactating women Known alle Other situations that the investigator considers unsuitable with respect to participating in the trial

Sites / Locations

  • First affiliated hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

Pathological Complete Response

Secondary Outcome Measures

Major pathologic response
Event-free survival
Disease-free survival
Overall survival

Full Information

First Posted
May 7, 2023
Last Updated
July 14, 2023
Sponsor
Weijia Fang, MD
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1. Study Identification

Unique Protocol Identification Number
NCT05862168
Brief Title
Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma :A Single-arm, Prospective, Phase II Trial
Official Title
Neoadjuvant Tislelizumab Combined With Albumin-paclitaxel, Cisplatin, and Fluorouracil in Patients With Locally Advanced Oral Squamous Cell Carcinoma :A Single-arm, Prospective,Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Weijia Fang, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Albumin paclitaxel
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Intervention 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.
Primary Outcome Measure Information:
Title
Pathological Complete Response
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Major pathologic response
Time Frame
6 months
Title
Event-free survival
Time Frame
2 years
Title
Disease-free survival
Time Frame
5 years
Title
Overall survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed the informed consent form Histopathological diagnosis of oral squamous cell carcinoma Age: 18-75 years old , Gender: male and female Primary tumor with a clinical stage of III/IVb (T1-2N+M0或T3-4N0-3M0, AJCC2018) Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1 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.); Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) 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% contraception Exclusion Criteria: Known history of malignancy, unless been cured and no recurrence for 5 years Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy Known history of radiation, chemotherapy, surgery and immunology-based treatment to head and neck 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. Active or previous definite inflammatory bowel disease (e.g., Crohn 's disease or ulcerative colitis) disease. Subjects with known active pulmonary tuberculosis (TB) and suspected active TB require clinical examination to rule out; known active syphilis infection. 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. Known human immunodeficiency virus (HIV) infection 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). History of pneumonitis/interstitial lung disease requiring systemic corticosteroids or current pneumonitis. Known allergic reaction to any ingredients or excipients of the therapy Participation in other clinical trials within 30 days before enrollment Pregnant or lactating women Known alle Other situations that the investigator considers unsuitable with respect to participating in the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lulu Liu, M.D.
Phone
0571-87237587
Email
liululu2001@zju.edu.cn
Facility Information:
Facility Name
First affiliated hospital, School of Medicine, Zhejiang University
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weijia Fang, Doctor

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma :A Single-arm, Prospective, Phase II Trial

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