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Globally, there are about 890,000 cases of neck cancer each year, resulting in 450,000 deaths.
more than 90% of head and neck cancer is head and neck squamous cell carcinoma (HNSCC), which mostly originates in the mouth or pharynx.
about 60% of patients are localized late stage (LA)-HNSCC, and about 25% are diagnosed with age 70 and older.
Phase I study evaluated the safety of the state-of-the-art radiation enhancer nanoparticle NBTXR3 in elderly or weak patients with local late-stage head and neck squamous cell carcinoma who were not suitable for chemotherapy.
study process This trial recruited patients aged 70 and over or over who were not suitable for cisplatin therapy and were not suitable for treatment with therapeutic radiotherapy (RT) in Stage III or IVA oral or oral pharynx HNSCC patients, given NBTXR3 single intraumma injections, and then enhanced radiotherapy (IMRT; 70Gy) to activate NBTXR3.
NBTXR3 dose corresponds to the percentage of baseline tumor volume.
the main objective is to determine the recommended phase II dose (RP2D), dose-limiting toxicity (DLTS), and maximum to-to-do dose (MTD).
NBTXR3 recruited a total of 19 patients in the tumor concentration: 3 5% dose level, 3 cases 10% dose level, 5 cases 15% dose level, 8 cases 22% tumor volume dose level.
did not reach MTD and no DLT or severe adverse events (SAEs) associated with NBTXR3 were observed.
reported 4 adverse events (I-II levels) related to NBTXR3 and/or IT injections.
the full bloodconcentration after NBTXR3 injection remained in the injected tumor throughout the radiotherapy process and did not leak into surrounding healthy tissue.
specific RT-related toxicity is consistent with IMRT expectations.
RP2D was determined to be 22% of the size of the baseline tumor.
, the researchers also initially observed signs of anti-tumor activity.
, imRT after intracology injection of NBTXR3 is feasible and shows good safety, which supports further evaluation of the program in this patient group.
