Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC
Neoadjuvant Toripalimab and Albumin Paclitaxel /Cisplatin Versus Docetaxel/ Cisplatin/ 5-fluorouracil (TPF) on Pathological Response in Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma
Shanghai Jiao Tong University School of Medicine
80 participants
Oct 1, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria11
- Age: 18-75 years old
- Gender: male and female
- Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2
- Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)
- Primary tumor with a clinical stage of III/IVA (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC2018)
- Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- Blood routine: white blood cells (WBCs) \>3,000/mm3, hemoglobin \>8 g/L, platelets \>80,000/mm3
- 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
- Renal function: Serum creatinine \<1.5 times the upper limit of normal
- Coagulation function: INR, PT, APTT\<1.5 times the upper limit of normal
- Signed the informed consent form
Exclusion Criteria13
- Unresolved grade 2 \[(Common Terminology Criteria for Adverse Events (CTCAE 5.0)\] or higher toxic reactions caused by previous anticancer treatments
- Known allergic reaction to any ingredients or excipients of the therapy
- Known history of malignancy, unless been cured and no recurrence for 5 years
- Known history of radiation to head and neck
- Active severe clinical infection (\> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection)
- Obvious cardiovascular abnormalities \[such as myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease diagnosed according to the New York Heart Association (NYHA) classification 3 months before enrollment\]
- Patients receiving immunology-based treatment for any reason
- Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy
- Pregnant or lactating women
- 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
- 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
- Participation in other clinical trials within 30 days before enrollment
- Other situations that the investigator considers unsuitable with respect to participating in the trial
Interventions
The participants will receive two cycles of Toripalimab, with 21 days each. 240mg of Toripalimab will be used intravenously on the first day of each cycle.
The participants will receive two cycles of Albumin paclitaxel, with 21 days each. 260mg/m\^2 of Albumin paclitaxel will be used intravenously on the first day of each cycle.
The participants will receive two cycles of Cisplatin, with 21 days each. 75mg/m\^2 of Cisplatin will be used intravenously on the first day of each cycle.
The participants will receive two cycles of Docetaxel, with 21 days each. 75mg/m\^2 of Docetaxel will be used intravenously on the first day of each cycle.
The participants will receive two cycles of 5-Fluorouracil, with 21 days each. 750mg/m\^2/d of 5-Fluorouracil will be used as a 120-hour continuous intravenous infusion on days 1 through 5.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05125055