A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer

Korábbi kezelés

• Subjects who had previously undergone total hysterectomy
• Subjects with other active malignancies within 2 years prior to randomization
• Any prior treatments targeting the mechanism of tumor immunity, such as immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PDL1 antibody, anti-CTLA-4 antibody, etc.), or therapy against immune costimulatory factors (e.g., antibodies directed against ICOS, CD40,CD137, GITR, OX40 targets, etc).
• Subjects who require systemic treatment with glucocorticoid (>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to randomization;
• Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study
• Use of live vaccines within 4 weeks prior to randomization
• Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug.

Más betegség

• Subjects with other histopathological types of cervical cancer, such as small cell carcinoma, sarcoma, etc.
• Active or potentially recurrent autoimmune disease
• Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
• Known history of interstitial lung disease or non-infectious pneumonitis

Egyéb

• FIGO 2018 IVB
• Subjects who cannot receive brachytherapy
• Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as judged by the Investigator
• Pregnant or lactating women.

• signs the written informed consent form
• ECOG 0-1
• Life expectancy ≥ 3 months.
• The histological types include squamous cell carcinoma,adenocarcinoma, or adenosquamous cell carcinoma;
• Locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage 3A-4A
• At least one measurable tumor lesion per RECIST v1.1
• Adequate organ function as assessed in the laboratory tests