Study design and participants
infection, sarcoma, hypersensitivity, synovial sarcoma
DISEASE, METASTATIC DISEASE, INFECTION, SARCOMA, SYNOVIAL SARCOMA, ONCOLOGY, HYPERSENSITIVITY
The study was designed as a two-stage, single arm phase II trial among patients with metastatic or locally advanced unresectable relapsed SS enrolled between March 2020 and September 2021. The eligible patients included those with histopathologically proven synovial sarcoma who had received at least one line of medical therapy and had progressed with unresectable locally advanced or metastatic disease. Patients were aged between 15 and 75 years with Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤ 2; with normal pre-treatment haematological and biochemical function and radiologically measurable disease. Patients who were pregnant or lactating, harbouring active infection, had a history of hypersensitivity to taxanes or exposed previously to gemcitabine and/or docetaxel, were excluded.The histological diagnosis was confirmed by two expert sarcoma pathologists at our institution (A.B. and A.M.). The study was carried out in accordance with Good Clinical Practice Guidelines after approval by the Institutional Review Board and provision of informed consent by the patient or their legal guardian (in patients aged less than 18 years).