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

• Status: Recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

Summary

To compare the pathological efficacy of neoadjuvant Toripalimab and Albumin paclitaxel /Cisplatin (TTP) with Docetaxel/ Cisplatin/ 5-flurouracil (TPF) for patients with locally advanced resectable oral squamous cell carcinoma (OSCC), and to determine the safety of neoadjuvant TTP. In order to explore a better protocol of neoadjuvant therapy to improve the efficacy in patients with locally advanced OSCC.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Docetaxel; Fluorouracil; Paclitaxel

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