Treatment protocol
toxicity, death
ADVERSE EVENTS, DISEASE PROGRESSION, DRUG ALLERGY
This study was conducted in accordance with the Good Clinical Practice guidelines, the Declaration of Helsinki, and the corresponding regulations issued by the National Medical Products Administration. The protocol was approved by the institutional review board of Beijing Shijitan Hospital. Written informed consent was obtained from all participating patients, in accordance with the principles described by the National Medical Products Administration. CGA injection was administered intramuscularly to patients once daily for 28 days. Before the first dose, the patients received an intracutaneous drug allergy test. The initial dose was 2 mg/kg, and the dose was escalated to 7 mg/kg according to a conventional 3 + 3 design, and a modified Fibonacci method. Dose reductions were not allowed, but patients with DLT were permitted to restart treatment if the toxicity decreased to grade 1 or 2, and the previous treatment was paused within 1 week. After the first cycle of the 28-day treatment, patients were eligible to continue multiple-cycle treatment until investigator-determined disease progression, unacceptable adverse events, withdrawal of consent, or death.