Actively Recruiting
Study Of Cadonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer
Led by Chongqing University Cancer Hospital · Updated on 2024-09-19
33
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
Sponsors
C
Chongqing University Cancer Hospital
Lead Sponsor
L
Liaoning Cancer Hospital & Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study Of Cadonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign written informed consent
- Women aged 18 years or older at study entry
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2
- Life expectancy of at least 12 weeks
- Intolerance to chemotherapy regimens
- Histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- No systemic anti-tumor therapy recently except concurrent chemotherapy
- Locally advanced cervical cancer (FIGO 2018 Stage IB3/IIA2, IIB-IVA)
- At least one measurable tumor lesion by RECIST v1.1 criteria
- Available archived tumor tissue samples or recent biopsies
- Adequate organ function
- For fertile women, negative serum pregnancy test and effective contraception within 7 days before treatment until 120 days after last study drug dose and at least 180 days after radiotherapy
You will not qualify if you...
- Other histological types of cervical cancer such as neuroendocrine carcinoma, small cell carcinoma, or sarcoma
- Evidence of distant metastases
- Prior total hysterectomy
- Other active malignancies within 2 years before study entry
- Unable to receive brachytherapy
- Active or prior autoimmune disease that may relapse
- History of interstitial lung disease or noninfectious pneumonitis
- Clinically significant cardio-cerebrovascular disease
- History of severe hypersensitivity reactions to monoclonal antibodies
- Prior allogeneic stem cell or organ transplantation
- Need for systemic glucocorticoids (>10 mg/day prednisone equivalent) or immunosuppressive agents within 14 days before study entry
- Receipt of live attenuated vaccines within 30 days before first study drug dose
- Prior exposure to experimental antitumor vaccines or agents targeting T-cell costimulation or immune checkpoints
- Any condition interfering with study drug evaluation or safety interpretation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chongqing university Cancer Hospital
Chongqing, CHN, China, 400000
Actively Recruiting
Research Team
X
Xingtao Long, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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