ameloblastoma, pleomorphic adenoma
Conditions
Interventions
primary ameloblastoma group:N/A
recurrent or malignant ameloblastoma group:N/A
primary pleomorphic adenoma group:N/A
recurrent or carcinoma ex pleomorphic adenoma group:N/A
Sponsors
West China Hospital of Stomatology, Sichuan University
Eligibility
Sex/Gender
All
Age
6 Years to 75 Years
Inclusion criteria
Inclusion criteria: a) Age >= 6 years and <= 75 years, male or female; b) Patients with pathologically confirmed borderline tumors and meeting the following conditions: i. patients with pleomorphic adenoma or ameloblastoma newly diagnosed, recurrent or malignant transformation; ii. patients who can be surgically removed after head and neck surgery evaluation; iii. willing to undergo surgical treatment; c) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; d) Adequate organ and bone marrow function; e) The subject voluntarily joins this study, signs an informed consent form, and is able to comply with protocol-specified visits and related procedures.
Exclusion criteria
Exclusion criteria: a) History of other malignant tumors (except cured non-melanoma in situ skin cancer, superficial bladder cancer, in situ cervical cancer, gastrointestinal intramucosal cancer, breast cancer, localized prostate cancer and other malignant tumors that the investigator considers can be included); b) Any active autoimmune disease or history of autoimmune disease, including but not limited to immune-related neurological disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease including Crohn 's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome (except type I diabetes mellitus with stable doses of insulin); c) Allergic diseases, history of severe drug allergy, known allergy to macromolecular protein preparations (note: severe allergy refers to allergy leading to hospitalization); d) Patients who have received any of the following treatments: i. patients who have previously used chemotherapeutic agents, PD-1 antibodies, PD-L1 antibodies, PD-L2 antibodies, CTLA-4 antibodies, or EGFR antibodies; ii. patients who have received anti-tumor vaccines; ii. patients who have received anti-tumor vaccines within 4 weeks before the first dose or plan to use any active vaccines against infectious diseases (such as influenza vaccines, varicella vaccines, etc.) during the study period; iv. patients who have undergone major surgery or have severe trauma within 4 weeks before the first dose; v. patients who have not recovered to less than CTCAE 5.0 version 1 (except alopecia, sequelae of previous platinum-related neurotoxicity) or levels specified in the inclusion/exclusion criteria; e) Patients with severe medical diseases, such as grade II and above cardiac dysfunction (NYHA standard), ischemic heart disease (such as myocardial infarction or angina pectoris), clinically significant supraventricular or ventricular arrhythmia, poorly controlled diabetes (fasting blood glucose >= 10 mmol/L), poorly controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg), echocardiography showed ejection fraction 450 msec, female > 470 msec; ECG abnormalities and the investigator considered there were additional risks to the test drugs; f) Subjects with known history of interstitial pneumonia, history of pneumonitis, or high suspicion of interstitial pneumonia; or subjects who may interfere with the detection or management of suspected drug-related pulmonary toxicity; subjects with previous drug-induced or radiation-induced pneumonitis but asymptomatic are allowed; subjects with active pulmonary tuberculosis, or those with previous history of pulmonary tuberculosis infection but uncontrolled by treatment; g) Patients with hyperthyroidism and patients with organic thyroid disease cannot be enrolled, and hypothyroidism that can be controlled with thyroid replacement hormone therapy can be enrolled (whether it can be controlled is confirmed by the investigator and/or endocrinology department); h) Active infection, or fever of unknown origin during screening, within 48 h prior to the first dose, or systemic antibiotics within 1 week prior to informed consent; i) Subjects with active hepatitis B (HBV DNA >= 2000 IU/ml or 104 copies/ml) or hepatitis C (hepatitis C antibody positive, a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence; | — |
Countries
China
Contacts
Public ContactLi Chunjie
West China Hospital of Stomatology, Sichuan University
Outcome results
None listed