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About
This is an open-label, multi-center Phase II study of cadonilimab (AK104) combined with chemotherapy in patients with recurrent or advanced endometrial cancer. The primary objective is to evaluate objective response rate of cadonilimab plus chemotherapy.
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Inclusion criteria
Hemoglobin of ≥90 g/L, white blood cell (WBC) ≥3×109/L, absolute neutrophil count (ANC) ≥1.5×109/L, platelets ≥100 ×109/L 2) Biochemical examination should meet the following criteria:
Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN (however, patients with known liver metastasis who have AST or ALT level ≤ 5 × ULN may be enrolled)
Serum creatinine ≤ 1.5 × ULN 3) Urine protein ≤(++) , or 24-hour urine protein quantification less than 1 g; 4) International standard ratio (INR) and activated partial thromboplastin time ≤1.5 uln (unless anticoagulant therapy is used because of disease) ; 12. Adverse events from any previous treatment, except for symptomatic stable sensory neuropathy or alopecia ≤ CTCAE Grade 2, have returned to ≤ CTCAE grade 1 or baseline, except anemia; 13. Women of childbearing potential should have a negative serum or urine pregnancy test prior to receiving the first dose of study treatment; and should be willing to use one acceptable contraception (i.e., oral contraceptives, condoms, intrauterine devices [IUDs]) throughout the period of taking study treatment and for at least 3 months after the last dose of study drug(s).
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
45 participants in 1 patient group
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Central trial contact
yang sun, doctor
Data sourced from clinicaltrials.gov
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