Study Of Cadonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer

Prior treatment

• Have received total hysterectomy.
• 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).

Other illness

• Other histological types of cervical cancer (eg, neuroendocrine carcinoma, small cell carcinoma, sarcoma, etc).
• 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.

Other

• Evidence of distant metastases.
• 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.
• Intolerance to chemotherapy regimens.
• Histologically confirmed cervical cancer.
  • Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix;
  • Not receiving systemic anti-tumour therapy (including but not limited to radiotherapy, targeted therapy and immunotherapy, etc; concurrent chemotherapy is not included. Note: Removal or biopsy of pelvic lymph nodes or para-aortic lymph nodes for the purpose of clinical staging is allowed).
  • Locally advanced cervical cancer（LACC）: The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage IB3/IIA2, IIB-IVA.
• 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)