thymic carcinoma
Conditions
Interventions
1:SHR-1316 plus nab-paclitaxel and carboplatin
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily join the study, sign the informed consent, and have good compliance; 2. Age 18-75 years old (including boundary values, calculated on the date of signing informed consent), both male and female; 3. Patients with thymic carcinoma confirmed by pathological examination; 4. Patients with unresectable UICC stage III or IV recurrent and metastatic thymic cancer who have not received any anti-tumor therapy (including but not limited to ICIs, targeted therapy, radiotherapy, chemotherapy, etc.). Patients with postoperative recurrence who had previously received neoadjuvant or adjuvant chemotherapy or chemoradiotherapy at least 6 months since the end of the previous treatment were admitted. 5. There is at least one measurable lesion that meets the RECIST v1.1 standard; 6. ECOG score: 0~1; 7. Expected survival =3 months; 8. The functions of vital organs meet the following requirements: 1) Hematology laboratory test indicators (no blood component and cell growth factor drug correction therapy is allowed within 14 days prior to screening), including: a. Absolute neutrophil count (ANC) =1.5 ×10^9/L; b. Platelet count (PLT) =100 × 10^9/L; c. Hemoglobin (Hb) = 90 g/L. 2) Kidney function, including: a. Serum creatinine (Cr) =1.5 × upper limit of normal reference value (ULN) or estimated creatinine clearance (Clcr) = 50 mL/min (calculated according to Cockcroft-Gault formula). 3) Heart function, including: a. Left ventricular ejection fraction (LVEF) =50%; 4) Liver function, including: a. Serum total bilirubin (TBIL) =1.5 × ULN; b. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3 × ULN (tumor with liver metastasis, = 5 × ULN); c. Alkaline phosphatase (ALP) = 2.5 × ULN; Or = 5 × ULN (if bone metastasis occurs). 5) Coagulation function, including: a. International Standardized ratio (INR) or prothrombin time (PT) =1.5 × ULN; b. Activated partial thromboplastin time (APTT) =1.5 × ULN. 9. Non-surgical sterilized female patients of reproductive age and male patients whose partners are women of reproductive age need to use highly effective contraception from the signing of informed consent until 6 months after the last dose; Serum HCG tests must be negative for women of childbearing age who are not sterilized surgically within 3 days prior to the first dose and must be non-lactating.
Exclusion criteria
Exclusion criteria: 1. Pathologically confirmed thymoma and thymic neuroendocrine tumor. 2. The subject has had or co-had other malignancies, including cured skin basal cell carcinoma, cervical carcinoma in situ, and breast ductal carcinoma in situ (DCIS), except other malignancies that have been treated and cured for =5 years prior to the first dose with evidence of no recurrence or metastasis; 3. The subject has cancerous meningitis or untreated central nervous system metastasis; Patients who had previously received systemic and radical brain metastases (radiotherapy or surgery), had been stable for at least 1 month as confirmed by imaging, had stopped systemic sex hormone therapy (dose >10mg/ day or other therapeutic hormones) for more than 2 weeks, and had no clinical symptoms could be included; 4. Large amount of cancerous ascites, pleural effusion and pericardial effusion accompanied by clinical symptoms without treatment; Or have received ascites, pleural effusion and pericardial effusion drainage within 14 days before the first medication; 5. Accompanied by poorly controlled tumor-related pain; 6. Persons with any active, known or suspected autoimmune disease (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, pituitaritis, hyperthyroidism, etc.). Type 1 diabetes was admitted for steady-dose insulin therapy, hypothyroidism for hormone replacement therapy only, systemic therapy was not required, and there were no acute worsening skin conditions (such as eczema, vitiligo, or psoriasis) in the 1 year prior to the screening period. 7. A history of immunodeficiency, including HIV testing positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation. 8. Previous or current interstitial pneumonia, drug-induced pneumonia, or active pneumonia shown by CT during screening; 9. Patients with active pulmonary tuberculosis who had been adequately treated and had stopped anti-tuberculosis therapy for = 3 months before the first medication could be enrolled. 10. Subjects with active hepatitis or co-infection with hepatitis B and hepatitis C (hepatitis B reference: HBsAg positive, HBV DNA=500 IU/ml and abnormal liver function; Hepatitis C reference: HCV antibody positive and HCV RNA higher than the lower limit of assay method detection); 11. Have clinical symptoms or diseases of heart that are not well controlled, such as: (1) NYHA grade 2 or above cardiac dysfunction, (2) unstable angina pectoris, (3) acute myocardial infarction within 1 year, (4) Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; 12. The subject has an active infection or unexplained fever =38.5? within 7 days prior to the first medication; 13. Known allergic reactions to any component of other monoclonal antibodies, or a history of severe allergy to albumin-paclitaxel, platinum-based drugs, or prophylactic drugs thereof; 14. Those who have previously received anti-PD-1 /PD-L1 monoclonal antibody or anti-CTLA-4 monoclonal antibody therapy; 15. Received any systematic anti-tumor therapy (including but not limited to immunization, targeting, radiotherapy, chemotherapy, etc.); 16. Received major surgical treatment or radiotherapy within 4 weeks before the first dose; 17. Subjects who have received systemic treatment with corticosteroids (>
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS;Duration of response;Disease control rate;OS;adverse event; | — |
Countries
China
Contacts
Public Contactfang wentao
Shanghai Chest Hospital
Outcome results
None listed