Neoadjuvant Immunochemotherapy for LAOSCC

Launched by LAI-PING ZHONG · Feb 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with locally advanced oral squamous cell carcinoma, which is a type of cancer that can affect areas like the tongue and gums. Researchers want to see how well a combination of immunotherapy (using a drug called tislelizumab) and chemotherapy (with albumin paclitaxel and cisplatin) works before surgery, compared to the standard treatment currently used. The goal is to find out if this new approach can improve outcomes for patients who can still have their tumors surgically removed.

To participate in the trial, patients need to be between the ages of 18 and 74, have a confirmed diagnosis of oral squamous cell carcinoma, and have specific health criteria that indicate they can handle the treatment. This includes having certain blood counts and liver and kidney function levels. Participants will receive the new treatment before surgery, followed by additional therapy afterward, and will be closely monitored throughout the process. It's important to note that some individuals, such as those with certain health conditions or previous cancer treatments, may not be eligible for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
• • 2. Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)
• • 3. Primary tumor with a clinical stage of III/IVA (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC 2018)
• • 4. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
• • 5. Blood routine: white blood cells (WBCs) \>3,000/mm3, hemoglobin \>8 g/L, platelets \>80,000/mm3
• • 6. 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
• • 7. Renal function: Serum creatinine \<1.5 times the upper limit of normal
• • 8. Coagulation function: INR、PT、APTT\<1.5 times the upper limit of normal
• • 9. Signed the informed consent form
• Exclusion Criteria:
• • 1. Unresolved grade 2 \[(Common Terminology Criteria for Adverse Events (CTCAE 5.0)\] or higher toxic reactions caused by previous anticancer treatments
• • 2. Known allergic reaction (grade 3-4) to any ingredients or excipients of the therapy
• • 3. Known history of malignancy, unless been cured and no recurrence for 5 years
• • 4. Known history of radiation to head and neck
• • 5. Active severe clinical infection (\> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection)
• • 6. Obvious cardiovascular abnormalities \[such as myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease diagnosed according to the New York Heart Association (NYHA) classification 3 months before enrollment\]
• • 7. Patients receiving immunology-based treatment for any reason
• • 8. Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy
• • 9. Pregnant or lactating women
• • 10. Known active hepatitis B or C. Active hepatitis B is defined as a known HBsA positive with HBV DNA≥500 IU/mL. Active hepatitis C is defined as a known hepatitis C antibody positive and a known amount of hepatitis C virus HCV RNA results greater than the lower limit of detection. The presence of other serious liver diseases, including chronic autoimmune liver disease, primary biliary cirrhosis or sclerosing cholangitis, alcoholic liver disease, or non-alcoholic steatohepatitis (NASH)
• • 11. Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or solid organ transplantation
• • 12. Participation in other clinical trials within 30 days before enrollment
• • 13. Other situations that the investigator considers unsuitable with respect to participating in the trial