Oral Cancer
Conditions
Interventions
High-risk group:Received neoadjuvant chemotherapy in combination with PD-1 blocker immunotherapy. The specific regimen is as follows: paclitaxel (175 mg/m2, d1) + cisplatin (75 mg/m2, d1) + tybosumuma
Low-risk group:Received neoadjuvant chemotherapy in combination with PD-1 blocker immunotherapy. The specific regimen is as follows: paclitaxel (175 mg/m2, d1) + cisplatin (75 mg/m2, d1) + tybosumumab
Sponsors
First Affiliated Hospital,Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Be at least 18 years old; (2) Non-recurrent, non-secondary tumors occurring in the oral cavity (3) Biopsy has been performed before radical surgery and histological report is squamous cell carcinoma; (3)Clinical stage III-IVa according to the 8th edition of the AJCC oral cancer stage, ; (4) ECOG score 0-1, and the patient's status allows cisplatin chemotherapy; (5) The patient has signed a written informed consent form; (6) Complete liver, kidney, endocrine and hematological function examination; (7) Female subjects of childbearing age who are negative within 3 days before starting treatment, and have a negative pregnancy test; (8) Female subjects of childbearing potential who are willing to use an adequate method of contraception until the end of the study.
Exclusion criteria
Exclusion criteria: (1) Concurrent participation in any other interventional clinical trial within one month prior to participation in this trial; (2) Diagnosed with immunodeficiency disease within 7 days prior to participating in the trial; (3) Confirmed diagnosis of active autoimmune disease within 2 years prior to participation in this trial and ongoing treatment with systemic steroids or any other form of immunosuppressive therapy; (4) Chemotherapy, targeted small molecule therapy, or radiotherapy within one month prior to participating in this trial; (5) Other malignancies are progressing or require continuous treatment; (6) Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy. (7) Diagnosed with type 1 diabetes mellitus or uncontrolled type 2 diabetes; (8) History of severe skin reactions, such as Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis or drug reactions with eosinophilia and systemic symptoms. (9) History of allergy to the drug or similar drug used in the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic response;Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;Local Recurrence-free survival;Distant Metastasis-free survival; | — |
Countries
china
Contacts
Public ContactHuiyong Zhu
First Affiliated Hospital,Zhejiang University School of Medicine
Outcome results
None listed