local advanced oral cancer in the context of oral submucous fibrosis
Conditions
Interventions
Test group:Penpulimab, Cisplatin (Carboplatin is used if cisplatin is not tolerated), Albumin-bound Paclitaxel
Sponsors
Hunan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in this study and sign the informed consent form. 2. >=18 yrs; =6 months. 4. Patients with pathologically confirmed locally advanced oral cancer (Stage III-IVb). 5. Patients with a betel nut chewing history of at least 10 years, or those who chew 10 or more betel nuts orally per day, and are accompanied by oral submucous fibrosis. 6. Have at least one measurable lesion (RECIST 1.1); 7. Main organs function well, with laboratory test indicators meeting the following requirements: (1) Routine blood test: a. Hemoglobin (HB) >= 90 g/L; b. Absolute Neutrophil Count (ANC) >= 1.5 × 10?/L, and total white blood cell count >= 3.5 × 10?/L; c. Platelet (PLT) >= 80 × 10?/L; (2) Blood biochemistry test: a. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) = 60 ml/min; (3) Coagulation function test: Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR), and Prothrombin Time (PT) = Lower Limit of Normal Value (50%). 8. Women of childbearing age must confirm a non-pregnant status before enrollment. All enrolled subjects (regardless of gender) should use adequate contraceptive measures throughout the entire treatment period and within 4 weeks after the end of treatment.
Exclusion criteria
Exclusion criteria: 1. Has received PD-1/PD-L1/CTLA-4 antibody therapy in the past. 2. Patients who require systemic administration of glucocorticoids (>10 mg prednisone equivalent per day) or other immunosuppressive drugs within 14 days prior to drug administration or during treatment. In the absence of active autoimmune diseases: Inhaled or topical steroids are permitted; Adrenocortical hormones with a dose exceeding 10 mg/day prednisone equivalent are permitted; Adrenocortical hormone replacement therapy with a dose not exceeding 10 mg/day prednisone equivalent is permitted. 3. Having a history of any active immune or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 4. Having an active or uncontrolled severe infection (>= Grade 2 infection per NCI CTCAE v5.0) within 4 weeks prior to enrollment. 5. Renal Insufficiency: Urinalysis indicates proteinuria of >= ++, or a confirmed 24-hour urinary protein excretion of >= 1.0 g. 6. Having a history of myocardial ischemia or myocardial infarction of Grade I or higher, arrhythmia (including QTc >= 480 ms), and congestive heart failure of Grade II or higher (New York Heart Association (NYHA) classification) within 6 months prior to enrollment. 7. Having been diagnosed with another malignant tumor within 3 years prior to enrollment; (Exceptions include resected basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma; patients with synchronous double cancers of the oral cavity, oropharynx, larynx, and hypopharynx that can be resected together during surgery are eligible for enrollment). 8. HIV-positive status; liver cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral treatment; patients with untreated chronic hepatitis B, hepatitis B virus (HBV) carriers with HBV DNA >= 500 IU/mL, or active hepatitis C virus (HCV) carriers should be excluded. Note: Non-active hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (with HBV DNA < 500 IU/mL), and cured hepatitis C patients are eligible for enrollment. 9. Participated in other anti-tumor drug clinical trials within 4 weeks before enrollment. 10. Individuals with a history of psychotropic substance abuse who are unable to abstain, or those with mental disorders. 11. As judged by the investigator, there are comorbidities or any other conditions that pose a serious risk to the patient's safety, may confound the study results, or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year distant metastasis-free survival rate;2-year overall survival rate;2-year disease-free survival rate;2-year local recurrence-free survival rate;Objective response rate;Pathological Complete Response; | — |
Countries
China
Contacts
Public ContactZhang Hailin
Hunan Cancer Hospital
Outcome results
None listed