Inoperable or recurrent and metastatic newly diagnosed thymic carcinoma
Conditions
Interventions
Experimental group:Immunotherapy + chemotherapy
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Prior to any trial-related procedures, a written informed consent form must be signed. 2. Age18 -75 years. 3. Pathologically confirmed Masaoka stage III/IV thymic carcinoma or locally treated progressing/recurrent thymic carcinoma, with no prior systemic drug therapy. 4. At least one radiologically measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Lesions within prior radiotherapy fields may be considered measurable if progression is confirmed. 5. ECOG (Eastern Cooperative Oncology Group) performance status score of 0–1. 6. Expected survival time >3 months. 7. Adequate organ function. Laboratory test results must meet the following criteria (assessed within 7 days prior to the first dose of study drug, with no blood transfusion or use of granulocyte-/platelet-boosting medications within 2 weeks before screening):Blood routine: Neutrophil (ANC) >=1.5×10^9/L; 1.Platelet count (PLT) >=100×10^9; 2.Hemoglobin (Hb) >=90g/L. Coagulation: International normalized ratio (INR), activated partial thromboplastin time (APTT) =0%; 6.Normal cardiac function, that is, normal or abnormal electrocardiogram examination has no clinical significance, and cardiac ultrasound shows left ventricular ejection fraction (LVEF) greater than 50%. Normal thyroid function is defined as thyroid stimulating hormone (TSH) being within the normal range. If the baseline TSH exceeds the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can also be enrolled. 8. Patients with previously treated brain metastases are eligible if asymptomatic without steroid therapy and with no progression after local treatment. 9. For females of childbearing potential: Use of highly effective contraception for )>=1 month before screening and agreement to continue during the study and for 1 year after the end of study medication. For males with fertile partners: Use of condoms or other methods to ensure effective contraception. 10. Voluntary participation in the study, with good compliance and willingness to adhere to follow-up.
Exclusion criteria
Exclusion criteria: 1. Prior systemic antitumor therapy for locally advanced or metastatic thymic carcinoma, including chemotherapy, immunotherapy, or biologics. 2. Major surgery within 4 weeks prior to study drug administration (excluding minor procedures deemed non-interfering by the investigator, e.g., tooth extraction) or planned major surgery during the study period. 3. Concurrent malignancies (excluding non-melanoma skin cancer and the following in situ cancers: bladder, gastric, colon, endometrial, cervical in situ/atypical hyperplasia, melanoma in situ, or breast in situ) unless in complete remission for >=2 years prior to enrollment with no ongoing or required therapy during the study. 4. Use of hematopoietic growth factors (e.g., granulocyte colony-stimulating factor [G-CSF], erythropoietin) within 1 week prior to the first dose of study drug. 5. Known hypersensitivity to any component of the study drug regimen. 6. Symptomatic brain metastases or brain metastases controlled for =Grade 3 per CTCAE within 4 weeks prior to the first dose, or unhealed wounds/ulcers/fractures. 16. Uncontrolled clinical conditions, including: Persistent/active severe infections; 1.Poorly controlled hypertension (persistent BP >150/90 mmHg); 2.Uncontrolled diabetes; 3.Cardiac disease (NYHA Class III/IV heart failure, cardiac block); 4.Active autoimmune diseases or history requiring systemic steroids/immunosuppressants (e.g., autoimmune hepatitis, interstitial pneumonia, vasculitis); 5.Exceptions: Vitiligo, psoriasis, alopecia, well-controlled type I diabetes, or hypothyroidism stable on hormone replacement. 17. History within 6 months prior to the first dose:Deep vein thrombosis, pulmonary embolism; 6.Myocardial infarction, severe/unstable arrhythmia, angina; 7.PCI, acute coronary syndrome, CABG; 8.Stroke, TIA, cerebral embolism. 18. Other conditions deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival;Safety;Duration of Response;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactZhehai Wang
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed