Cadonilimab with radiotherapy for locally advanced cervical cancer
Tests cadonilimab plus radiotherapy in adults with cervical cancer unable to tolerate chemotherapy.
Plain-language title generated from the registry record
Registry title: Study Of Cadonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer
Key facts
- Where
- Chongqing, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with locally advanced cervical cancer who cannot tolerate chemotherapy. They would get cadonilimab together with radiotherapy.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Cervical cancer confirmed by tissue test (squamous cell, adenocarcinoma or adenosquamous), FIGO 2018 stage IB3/IIA2 or IIB-IVA, with at least one measurable tumor lesion
- Earlier treatment
- Cannot tolerate chemotherapy. No earlier anti-tumour treatment such as radiotherapy, targeted therapy or immunotherapy. No earlier treatment with anti-PD-1, anti-PD-L1, anti-CTLA-4 or similar antibodies or experimental anti-tumour vaccines.
- Biomarker or test result
- Stored tumor tissue or a recent biopsy must be available
Main reasons for not taking part
- Other types of cervical cancer, such as neuroendocrine, small cell or sarcoma
- Cancer that has spread to distant parts of the body
- Total hysterectomy already done
- Cannot receive brachytherapy
- Autoimmune disease that may come back, or earlier interstitial lung disease or pneumonitis
Read by machine on 9 November 2026.
Where in China
- Chongqing University Cancer HospitalChongqing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chongqing University Cancer Hospital
- Trial code
- NCT05687851
- Record updated
- 19 September 2024
- Original description
Cadonilimab（AK104）is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.Read full original descriptionShow less
A Single-arm, Multicenter, Phase II Study to Evaluate Cadonilimab（AK104） Combined With Radiotherapy For The Treatment of Locally Advanced Cervical Cancer
Cadonilimab（AK104）is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.
This is a single-arm, multicenter, open-label, phase II study, the purpose of this study is to evaluate the efficacy and safety of Cadonilimab plus radiotherapy in participants with locally advanced cervical cancer who do not tolerate chemotherapy.
Inclusion: 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).
Exclusion: 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 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; Evidence of distant metastases; Subject who cannot receive brachytherapy.