Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC

Launched by SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Nov 17, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating two different treatment options for patients with locally advanced oral squamous cell carcinoma (OSCC), a type of mouth cancer. The trial aims to compare the effectiveness of a new combination therapy called Toripalimab with albumin paclitaxel and cisplatin (TTP) to a standard chemotherapy regimen known as TPF, which includes docetaxel, cisplatin, and 5-fluorouracil. Researchers want to find out which treatment works better in helping patients achieve a positive response before surgery and to assess how safe the new treatment is.

To join this study, participants need to be between 18 and 75 years old and have a confirmed diagnosis of OSCC at a specific stage. They should be in good overall health, with manageable side effects from any previous treatments. This trial is currently recruiting participants, and those who join will receive either the new treatment or the standard chemotherapy. Throughout the trial, participants will be closely monitored for their health and any side effects. This research aims to improve treatment options for patients facing this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 18-75 years old
• • 2. Gender: male and female
• • 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2
• • 4. Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)
• • 5. Primary tumor with a clinical stage of III/IVA (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC2018)
• • 6. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
• • 7. Blood routine: white blood cells (WBCs) \>3,000/mm3, hemoglobin \>8 g/L, platelets \>80,000/mm3
• • 8. 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
• • 9. Renal function: Serum creatinine \<1.5 times the upper limit of normal
• • 10. Coagulation function: INR, PT, APTT\<1.5 times the upper limit of normal
• • 11. 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 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. Uncontrollable hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>90 mmHg) or cardiovascular diseases with clinical significance (such as activity), such as cerebrovascular accidents (≤ 6 months before screening), myocardial infarction (≤6 months before screening), unstable angina pectoris, NYHA grade II or above congestive heart failure, or severe arrhythmia that cannot be controlled by drugs or has a potential impact on trial treatment
• • 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