Establishment and Validation of Prediction Model of Simultaneous Chemoradiotherapy for Cervical Cancer Organoids

Korábbi kezelés

• Subject with other active malignancies within 2 years prior enter the study.
• Active or prior documented autoimmune disease that may relapse.
• Prior allogeneic stem cell transplantation or organ transplantation.
• Subjects who require systemic treatment with glucocorticoid (>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior enter the study.
• Receipt of live attenuated vaccines within 30 days prior to the first dose of the study drug.
• Prior exposure to any experimental antitumor vaccines, or any agent targeting T-cell costimulation or immune checkpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-CD137 or anti-OX40 antibody, etc).

Más betegség

• History of interstitial lung disease or noninfectious pneumonitis.
• Subject with the clinically significant cardio-cerebrovascular disease.
• History of severe hypersensitivity reactions to other mAbs.
• Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the study drug or interpretation of subject safety or study results.
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Egyéb

• Subject who cannot receive brachytherapy.

• Able to understand and voluntarily sign written informed consent.
• Women aged ≥18 years at the time of study entry.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2.Life expectancy ≥12 weeks.
• Histologically confirmed cervical cancer.
• Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma，villous duct carcinoma, invasive mucinous multilayer carcinoma, gastric adenocarcinoma, mesrenal duct carcinoma, clear cell carcinoma, serous carcinoma, endometrioid adenocarcinoma and small cell carcinoma，Intestinal-type adenocarcinoma of the cervix;
• At least one measurable tumor lesion according to RECIST v1.1 criteria.
• Available archived tumor tissue samples or recent biopsies.
• Adequate organ function.
• For fertile women with negative serum pregnancy and effective contraception within 7 days before administration (until 120 days after the last administration of the study drug and at least 180 days after radiotherapy)