Status and phase
Conditions
Treatments
About
This study was an open, single-arm, enriched, multicenter Phase II study.
Full description
The trial was divided into screening period, treatment period and follow-up period. Participants entered the screening period after signing informed consent and met the inclusion criteria. Subjects who did not meet the exclusion criteria were treated with F520 monotherapy, intravenously, at 3mg/kg every 3 weeks until disease progression or intolerable toxicity or withdrawal for other reasons, for a maximum of 2 years.
Enrollment
Sex
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Volunteers
Inclusion criteria
Blood routine: Absolute neutrophil count ≥1.5×109/L; Platelet ≥75×109/L; Hemoglobin ≥90g/L; Liver function: TBIL≤1.5×ULN, ALT and AST≤2.5×ULN; If liver metastasis was present, TBIL≤3×ULN, ALT and AST≤5×ULN; Renal function: serum creatinine (Cr) ≤1.5×ULN; Thyroid stimulating hormone (TSH) in the normal range; If TSH is abnormal, free triiodothyronine (FT3) and free thyroxine (FT4) must be normal or abnormal without clinical significance.
International Normalized ratio (INR) ≤1.5×ULN and activated partial thromboplastin time (APTT) ≤1.5×ULN.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
29 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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