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
Single group
Sacituzumab Tirumotecan (Sac-TMT)
DrugSacituzumab tirumotecan at 4 mg/kg is administered intravenously on Day 1 and Day 15 of each 28-day cycle and continued until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met. The maximum exposure period for sacituzumab tirumotecan is 78 cycles (approximately 3 years).
Objective response rate based on central image review
The primary endpoint is the objective response rate based on central image review. It is defined as the proportion of patients in the FAS who achieved either a CR or PR based on the best overall response determined by central imaging review.
Objective response rate based on investigator assessment
The proportion of patients in the FAS group whose best overall response, as assessed by the treating physician at each study site, is either CR or PR.
Progression-free survival
The period from the registration date to the earlier of the date of progression or the date of death from any cause. Note that PD based on imaging studies will use the institution's assessment.
Overall survival
The period from the registration date to the date of death from any cause is considered overall survival.
Duration of response
The period from the date of initial PR/CR confirmation based on imaging assessment to the earlier of the date of confirmed disease progression or the date of death from any cause. The date of PR/CR confirmation is defined as the first day on which confirmed PR/CR was observed. Definitions for progression and discontinuation are the same as those used for progression-free survival.
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