A Phase I Clinical Trial of Neoadjuvant Chemotherapy With/Without SPIONs/SMF for Patients With Osteosarcoma

Inclusion Criteria: * Signed informed consent form * Biopsy-confirmed cancer diagnosis * Has at least one tumor lesion that can be accurately measured according to RECIST 1.1. and is amenable for intratumoral injection * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Life expectancy \>12 weeks * Karnofsky performance status (KPS) ≥ 70 * Adequate function of organs and bone marrow * Negative pregnancy test ≤ 7 days prior to SPIONs injection Exclusion Criteria: * Symptomatic central nervous system metastases and/or carcinomatous meningitis * Known HIV or active hepatitis B/C infection * Active infection requiring systemic treatment * Received a live virus vaccine within 30 days prior to study treatment * History of pneumonitis that required steroids or with current pneumonitis * Has received prior systemic anti-neoplastic therapy, within 4 weeks prior to SPIONs injection * Clinically significant cardiac arrhythmias * Class III or IV Congestive Heart Failure as defined by the New York Heart Association functional classification system \< 6 months prior to screening * A pregnant or nursing female, or women of child-bearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception * Any condition for which participation would not be in the best interest of the participant * Patients unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures or those with severe psychiatric illness/social situations that would limit compliance with study requirements * Patients participating in another clinical investigation at the time of signature of the informed consent