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