This is a non-randomized, open-label, investigator-initiated phase II clinical trial designed to evaluate the efficacy and safety of sacituzumab tirumotecan (hereafter referred to as sac-TMT) in patients with unresectable thymic carcinoma who have a history of platinum-based combination chemotherapy.
Pathologically diagnosed (histological or cytological examination) as thymic carcinoma originating in the thymus or from a metastatic site Immunohistochemical staining including diagnostic marker testing is recommended. If performed prior to registration, the timing is not restricted. However, if histological examination was conducted at another institution, the pathological diagnosis must generally be obtained by a pathologist at the study site, e.g., by requesting the pathological specimen.)
Thymic carcinoma was classified as Stage IV by the Masaoka-Koga staging at initial diagnosis
Thymic carcinoma was classified as Stage III by the Masaoka-Koga staging at initial diagnosis and was judged to be unresectable with curative resection
The disease is a postoperative recurrence of thymic carcinoma
Patients with thymoma and immune complications associated with thymoma (such as myasthenia gravis, aplastic anemia, hypogammaglobulinemia (Good syndrome), etc.)
Patients with intestinal paralysis or intestinal obstruction
Patients with a history of severe dry eye syndrome, severe meibomian gland disease, or severe corneal disease (impeding or delaying corneal healing)
Uncontrolled major cardiovascular or cerebrovascular disease (NYHA Class III or IV heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, QTcF interval >480 ms, or other major cardiovascular or cerebrovascular disease within 6 months prior to enrollment