Status:
UNKNOWN
A Prospective, Single-arm Phase II Clinical Trial of Tislelizumab Combined With Platinum Doublet Neoadjuvant Therapy to Improve Mandibular Preservation in Resectable Locally Advanced Oral Squamous Cell Carcinoma.
Lead Sponsor:
Xuekui Liu
Conditions:
Oral Squamous Cell Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Given the feasibility of induction chemotherapy in oral cancer and the encouraging remission rates achieved, we explore the clinical application prospects of using tislelizumab in combination with tra...
Detailed Description
In this study, eligible subject will be enrolled into study arm to accept study treatment mandibular Preservation Rate will be the primary outcome measures.
Eligibility Criteria
Inclusion
- Patients must have a confirmed diagnosis of untreated primary oral squamous cell carcinoma, originating from the buccal mucosa, gums, tongue, or floor of the mouth, with clinical imaging confirming no mandibular invasion. Even in the absence of mandibular invasion, patients must still require mandibular segment resection.
- Clinical staging should be T3-4N0-3M0 (Stage III-IVb, excluding T1-2) according to the AJCC 8th edition staging.
- Patients must be aged between 18 and 70 years. Performance Status (PS) score should be 0-1. Evaluation by a head and neck oncologist should confirm eligibility for surgical resection.
- Patients should have at least one evaluable lesion according to RECIST V1.1 criteria.
- Adequate organ function is defined as follows:
- Hematology: White blood cells ≥ 4000/μL, neutrophils ≥ 2,000/μL, hemoglobin ≥ 90 g/dL, platelets ≥ 100,000/μL.
- Liver function: Bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin levels ≤ 3 times ULN may be eligible), AST and ALT ≤ 3 times ULN, and alkaline phosphatase ≤ 3 times ULN, with albumin ≥ 3 g/dL.
- Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min according to the Cockcroft-Gault formula.
- Coagulation parameters (APTT and INR) should be ≤ 1.5 × ULN (patients on stable anticoagulation therapy such as low molecular weight heparin or warfarin within the expected therapeutic range may be screened).
- Thyroid-stimulating hormone (TSH) should be ≤ ULN. If abnormal, T3 and T4 levels should be assessed, and patients with normal T3 and T4 levels may be eligible.
- Patients must have provided informed consent and must be willing and able to adhere to the study plan, visit schedule, treatment plan, laboratory tests, and other study procedures.
- Reproductive-age females must agree to use contraceptive measures (e.g., intrauterine device, birth control pills, or condoms) during the treatment period and for three months after treatment completion. A negative serum or urine pregnancy test within 7 days before study entry is required, and patients must not be breastfeeding. Male patients must also agree to use contraceptive measures during the study and for three months after study completion.
Exclusion
Key Trial Info
Start Date :
November 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 25 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06130007
Start Date
November 25 2023
End Date
October 25 2024
Last Update
November 13 2023
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