- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05862168
Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma :A Single-arm, Prospective, Phase II Trial
July 14, 2023 updated by: Weijia Fang, MD
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lulu Liu, M.D.
- Phone Number: 0571-87237587
- Email: liululu2001@zju.edu.cn
Study Locations
-
-
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Hangzhou, China
- Recruiting
- First affiliated hospital, School of Medicine, Zhejiang University
-
Contact:
- Weijia Fang, Doctor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
|
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.
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pathological Complete Response
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 5 years
|
5 years
|
Disease-free survival
Time Frame: 5 years
|
5 years
|
Event-free survival
Time Frame: 2 years
|
2 years
|
Major pathologic response
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 8, 2023
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
June 30, 2028
Study Registration Dates
First Submitted
May 7, 2023
First Submitted That Met QC Criteria
May 7, 2023
First Posted (Actual)
May 17, 2023
Study Record Updates
Last Update Posted (Actual)
July 17, 2023
Last Update Submitted That Met QC Criteria
July 14, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Head and Neck Neoplasms
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Paclitaxel
- Fluorouracil
- Tislelizumab
Other Study ID Numbers
- Neo-TIME
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Oral Squamous Cell Carcinoma
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)TerminatedStage I Oral Cavity Squamous Cell Carcinoma | Stage II Oral Cavity Squamous Cell CarcinomaUnited States
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