Oral leukoplakia and oral erythema
Conditions
Interventions
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent; 2. Males and females aged 18 years and over and less than 80 years old; 3. ECOG score 0-2; 4. Subjects must have histologically confirmed oral leukoplakia, oral erythema, or proliferative verrucous leukoplakia (PVL). Lesions can be measured in a two-dimensional range, are not amenable to surgical resection, or refuse surgery. Patients must have at least 2 lesions that can be followed for treatment. (Patients who have undergone complete resection of the lesion and have no clinical evidence of disease will not be eligible for the study); 5. Baseline biopsy specimens can be used for relevant analysis or willing to undergo new baseline and post-treatment biopsies; 6. Able to cooperate in taking photos of lesions; 7. Adequate organ and bone marrow function: a. Routine blood count: leukocyte >=3x10^9/L; neutrophil > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 9 g/dL; b. Liver function satisfies the following: serum total bilirubin (TBIL) =60ml/min/1.73 m^2; 8. Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug. If the urine test is positive or cannot be confirmed negative, a serum pregnancy test is required; 9. Female subjects of childbearing potential should be willing to use two methods of birth control or surgical sterilization, or abstain from sexual activity during the course of the study until 5 months after the last dose. "Female of childbearing potential" is defined as any woman who has experienced menarche and has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal. Menopause is clinically defined as 12 months of amenorrhea in women over the age of 45 without other biological or physiological causes. In addition, females under 55 years of age must have a documented serum follicle-stimulating hormone (FSH) level of less than 40 mIU/mL; 10. Male subjects should agree to use any method of contraception with a failure rate of less than 1% from the first dose of study treatment until 7 months after the last dose of study treatment.
Exclusion criteria
Exclusion criteria: 1. Known carcinoma in situ or invasive squamous cell carcinoma of the oral cavity. Prior stage III (T1-2N1, T3N0) or stage IV (T1-3N2, T4N0) aggressive squamous cell carcinoma of the head and neck with surgery and radiation therapy, with or without chemotherapy. Patients with locoregional advanced tumors who have received prior surgery only are eligible; 2. Currently enrolled in and receiving other investigational treatments; 3. Prior immunotherapy (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint receptors); 4. Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies); 5. Any positive test result for hepatitis B virus or hepatitis C virus indicates the presence of the virus, such as hepatitis B surface antigen (HBsAg) positive, or hepatitis C antibody (anti-HCV) positive (except HCV-RNA negative); 6. Have active infection or active tuberculosis requiring systemic treatment; 7. Clinically significant cardiovascular disease, such as New York Heart Association Class III-IV heart failure, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction within the past 12 months; 8. Active, known, or suspected autoimmune disease. Subjects with cured childhood asthma, type I diabetes mellitus, and hypothyroidism requiring only hormone replacement are excluded, or skin conditions that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia); 9. Prior diagnosis of immunodeficiency, or organ transplantation requiring immunosuppressive therapy, or receiving systemic steroid therapy > prednisone 20mg/d (or equivalent dose), or receiving any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. In the absence of active autoimmune disease, inhaled or topical steroids, steroids as promedications for hypersensitivity reactions, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency are permitted; 10. Severe neurological or psychiatric disease, substance abuse, that would interfere with the conduct of the study; 11. Other serious underlying diseases that may impair the patient's ability to participate in the study; 12. Received a live vaccine within 30 days of planned initiation of study treatment; 13. Known allergic/hypersensitivity reaction to any ingredient of the treatment; 14. Pregnant or breastfeeding, or expecting to become pregnant or give birth to a child during the study time (from pre-screening until 7 months after the last dose of trial treatment); 15. Known to have other malignancies that are progressing or require active treatment, with the exception of: basal cell carcinoma of the skin; carcinoma in situ of the cervix; carcinoma in situ of the bladder; carcinoma in situ of the breast; low-risk prostate adenocarcinoma under active surveillance; 16. Lack of legal capacity or limited legal capacity; 17. Patients with long-term betel nut chewing (>= once a day for more than one year), current smoking or quitting smoking for less than one year, excessive alcohol consumption (more than 14 standard units per week, or continuous drinking for more than 10 years), occupational carcinogenic exposure, or poor oral hygiene were excluded. 18. Has a history or evidence of any other disease, treatment, or laboratory abnormality that, in the opinion of the treati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in measurements of the site of oral leukoplakia and/or erythema before and after administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects; | — |
Countries
China
Contacts
Public ContactXingchen Peng
West China Hospital of Sichuan University
Outcome results
None listed