Thymic Carcinoma
Conditions
Interventions
Experimental group:4-cycle treatment of Penpulimab (AK105) in combination with chemotherapy
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed thymic carcinoma (excluding thymoma components) by a pathologist. 2. Age = 18 years and = 75 years. 3. ECOG or PS score of 0 or 1. 4. Patients previously untreated for thymic carcinoma-related chemotherapy, radiotherapy, surgery, and immunotherapy, etc. 5. Clinical TNM stage I (T1b) - IV. 6. Normal function of major organ systems, meeting the following criteria: a) Hematological parameters (without blood transfusion or hematopoietic growth factors within 14 days): Hemoglobin (Hb) = 90g/L; Absolute Neutrophil Count (ANC) = 1.5×10^9/L; Platelet count (PLT) = 90×10^9/L; b) Biochemical parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) = 2.5×ULN (= 5×ULN for patients with tumor liver metastasis); Total Bilirubin (TBIL) = 1.5×ULN (= 3×ULN for patients with Gilbert syndrome); Serum Creatinine (Cr) = 1.5×ULN, and Creatinine Clearance Rate = 60 mL/min. c) Coagulation function: Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR), Prothrombin Time (PT) = 1.5×ULN; d) Doppler ultrasound assessment: Left Ventricular Ejection Fraction (LVEF) = 50%. 7. Reproductive-age women must agree to use contraception during the study and for 6 months after the study ends (such as intrauterine devices [IUD], contraceptive pills, or condoms); a negative serum or urine pregnancy test within 7 days before entry into the study, and must be non-lactating patients. Male patients must also agree to use contraception during the study and for 6 months after the study ends. 8. Patients must voluntarily participate in this study, sign an informed consent form, and exhibit good compliance.
Exclusion criteria
Exclusion criteria: 1. Patients using other investigational drugs simultaneously. 2. Patients with symptomatic brain metastases or with symptom control duration of less than 4 weeks. 3. Patients with a history of other malignancies within 5 years (excluding cured basal cell carcinoma and cervical carcinoma in situ). 4. Patients previously treated with PD-1/PD-L1/CTLA-4 antibodies. 5. Patients with uncontrollable recurrent pleural effusion, pericardial effusion, or ascites (as judged by the investigator). 6. Patients with spinal cord compression that has not been cured or relieved by surgery and/or radiotherapy, or previously diagnosed spinal cord compression with no clinical evidence of stability for =1 week before entry. 7. Patients who have undergone major surgery or experienced severe traumatic injury, fractures, or ulcers within 4 weeks before entry, or have had abdominal fistulas, gastrointestinal perforations, or intra-abdominal abscesses within 6 months before entry, or have long-standing unhealed wounds or fractures. 8. Patients who have experienced venous or arterial thromboembolic events within 6 months before the first dose, such as cerebrovascular accident (including transient ischemic attacks), deep venous thrombosis, and pulmonary embolism. 9. Patients with a history of substance abuse disorders who are unable to abstain or have psychiatric disorders. 10. Patients with any severe and/or uncontrollable diseases, including: a) Poorly controlled blood pressure (systolic blood pressure = 150 mmHg, diastolic blood pressure = 100 mmHg); b) History of grade I or higher myocardial ischemia or myocardial infarction, arrhythmias (including QTc = 450ms in males, QTc = 470ms in females), and = Grade 2 congestive heart failure (New York Heart Association [NYHA] classification); c) Active or uncontrollable severe infections (= CTC AE Grade 2); d) Cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral treatment (active hepatitis for reference [HBV: HBsAg positive, with HBV DNA levels exceeding the upper limit of normal; HCV: HCV antibody positive, with HCV viral load exceeding the upper limit of normal]); e) HIV-positive; f) Poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L); g) Urine analysis showing urine protein =++, and confirmed 24-hour urine protein quantification > 1.0 g. 11. Vaccination with preventive or attenuated vaccines within 4 weeks before the first dose. 12. Severe hypersensitivity reactions following administration of other monoclonal antibodies. 13. Active autoimmune diseases requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years before the first dose, including but not limited to myasthenia gravis, pure red cell aplasia, hypogammaglobulinemia, systemic lupus erythematosus, psoriasis, inflammatory bowel disease, Hashimoto's thyroiditis, etc. Replacement therapy (e.g., thyroid hormones, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment. 14. Diagnosed with immunodeficiency or receiving systemic glucocorticoid treatment or any other form of immunosuppressive therapy (dose > 10 mg/day of prednisone or equivalent) and still on therapy within 2 weeks before the first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate;Major Pathological Response Rate;Disease Control Rate;R0 Resection Rate;Disease-Free Survival;Overall Survival;1-year Survival Rates;2-year Survival Rates;3-year Survival Rates;Quality of Life;Safety; | — |
Countries
China
Contacts
Public ContactCheng Chao
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed