thymic carcinoma
Conditions
Interventions
Test group: SH1316+ nab-paclitaxel+ 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; Age 18-75 years old (including boundary values, calculated on the date of signing informed consent), both male and female. 2. Histologically confirmed thymic carcinoma. 3. Potentially unresectable locally advanced (T3-4NxM0) tumors. No previous treatment for thymic carcinomas, including but not limited to surgery, local radiotherapy, chemotherapy, immunotherapy, targeting therapy, and other experimental drug therapy. 4. Have at least one measurable lesion that meets RECIST 1.1 standards. 5. ECOG PS score: 0-1. 6. Expected survival =3 months. 7. Vital organ functions must meet the following criteria: 1) Blood routine examination: (no blood transfusion, no G-CSF and other cytogenic drugs were used within 2 weeks before screening); a) Hemoglobin (HB) =90 g/L; b) Neutrophil count absolute value (ANC) =1.5×10^9/L; c) Platelet count (PLT) =90×10^9/L; d) White blood cell count (WBC) =3.0×10^9/L and < 15×10^9/L; 2) Other tests: (did not receive human blood albumin injection within 14 days prior to screening) a) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3×ULN; b) Total bilirubin (TBIL) =1.5×ULN; c) Albumin (ALB) =30 g/L; d) Creatinine (Cr) =1.5×ULN, or creatinine clearance (CrCL) =50mL/min (Cockcroft-Gault formula); e) Thyroid stimulating hormone (TSH) =1×ULN (if TSH is abnormal, FT3/T3 and FT4/T4 levels should be investigated at the same time. If FT3/T3 and FT4/T4 are normal, they can be included in the group); f) Activated partial thromboplastin time (APTT) =1.5×ULN, International Standardized Ratio (INR) or prothrombin time (PT) =1.5×ULN (no anticoagulant therapy); g) Left ventricular ejection fraction (LVEF) =50%. 8. Non-surgical sterilization or female patients of childbearing age must undergo a serum pregnancy test within 3 days before the first medication, and the result is negative; And must be non-lactating. Female patients of reproductive age or male patients whose partners are women of reproductive age must consent to use highly effective methods of contraception during the study period and for 6 months after the last dose of the study drug. 9. The patient voluntarily joined the clinical study and signed the informed consent. The patient had good compliance and could cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with thymoma and thymic neuroendocrine tumor. 2. Patients with other malignant tumors within the past 3 years or at the same time, except cured skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, cervical carcinoma in situ, and breast ductal carcinoma in situ. 3. Previous or current interstitial pneumonia/interstitial lung disease (except for those with imaging changes only), pneumonia requiring systemic glucocorticoid treatment (such as radial pneumonia); Patients with active pneumonia or severe impairment of lung function confirmed by pulmonary function tests. 4. Persons with any active or known 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 admitted for steady-dose insulin therapy, hypothyroidism requiring hormone replacement therapy, no systemic therapy and no acute worsening skin conditions (such as eczema, vitiligo or psoriasis) in the 1 year before the screening period; Patients with asthma requiring medical intervention with bronchodilators were not included. 5. Patients with active pulmonary tuberculosis. Patients who had received adequate treatment before screeningt and had stopped anti-tuberculosis therapy for =3 months could be enrolled. 6. Heart diseases that are not well controlled, such as: (1) New York Heart Association (NYHA) Grade 2 and above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, and (4) Clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention. 7. Subjects who have had serious infections within 1 month before starting treatment, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc.; Subjects with any active infection or who developed an unexplained fever > 38.5 ° C during screening, prior to first dosing. 8. Known history of testing positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). Known to have active viral hepatitis. Hepatitis B reference: HBsAg positive, and HBV DNA test value of more than 500 IU; Hepatitis C reference: HCV antibody positive, and HCV virus titer test value exceeds the upper limit of normal). 9. Known allergic reactions to SH1316 or other PD-(L)1 monoclonal antibodies, or a history of severe allergic reactions to paclitaxel and platinum drugs or their prophylactics. 10. Received major surgical treatment, systemic chemotherapy, immunotherapy or other clinical trial drugs within 4 weeks prior to treatment; Received palliative radiotherapy within 2 weeks prior to treatment; Oral molecular targeting drugs, less than 5 half-lives from drug withdrawal to treatment; Or have used antibiotics within 1 week prior to treatment; Failure to recover from toxicity and/or complications from previous interventions to NCI-CTCAE=1 degree (except for alopecia and fatigue, as well as indicators mentioned in the inclusion criteria). 11. According to the researchers' judgment, the safety of drug use will be affected by other factors that may affect the results of the study or force the study to be terminated in the middle of the study, such as alcoholism, drug abuse, drug abuse, other serious diseases (including mental illness) requiring combined treat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of surgery;rate of complete resection;pathological response;progression-free survival, PFS;overall survival, OS;adverse event; | — |
Countries
China
Contacts
Public ContactWENTAO FANG
Shanghai Chest Hospital
Outcome results
None listed