Actively Recruiting
A Single-arm, Multicenter, Phase II Study to Evaluate Cadonilimab (AK104) Combined With Radiotherapy for Locally Advanced Cervical Cancer
Led by Chongqing University Cancer Hospital · Updated on 2024-09-19
33
Participants Needed
1
Research Sites
100 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
Researchers are evaluating the efficacy and safety of Cadonilimab (AK104), a humanized IgG1 bispecific antibody targeting PD-1 and CTLA-4, combined with radiotherapy in women with locally advanced cervical cancer who cannot tolerate chemotherapy. This phase II, single-arm, multicenter, open-label study aims to explore treatment options for this specific group of patients. The study is sponsored by Chongqing University Cancer Hospital and focuses on improving outcomes for those with this challenging condition. Participants receive Cadonilimab at a dose of 10 mg/kg every three weeks via intravenous infusion. Along with Cadonilimab, they receive radiotherapy that includes external beam radiotherapy (EBRT) followed by brachytherapy (BT). The treatment continues until disease progression, intolerable side effects, withdrawal of consent, or for up to two years. The radiotherapy doses are 45-50.4Gy for EBRT and at least 80Gy for brachytherapy. During the study, participants will be closely monitored with evaluations up to two years for overall response rate. Secondary measures include disease control rate, progression-free survival, overall survival, quality of life assessments using the EORTC QLQ-C30 questionnaire, and recording any adverse events. The total observation period extends up to about 40 months to assess longer-term outcomes and safety.
CONDITIONS
Brief 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.
- Female aged 18 years or older.
- 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.
- Not currently receiving systemic anti-tumor therapy (except concurrent chemotherapy).
- Diagnosed with locally advanced cervical cancer (FIGO 2018 Stage IB3/IIA2, IIB-IVA).
- At least one measurable tumor lesion per RECIST v1.1 criteria.
- Available archived tumor tissue samples or recent biopsies.
- Adequate organ function.
- Fertile women must have negative serum pregnancy test and use effective contraception from 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 (e.g., neuroendocrine carcinoma, small cell carcinoma, sarcoma).
- Evidence of distant metastases.
- Previous total hysterectomy.
- Other active malignancies within 2 years prior to study entry.
- Inability to receive brachytherapy.
- Active or prior autoimmune disease that may relapse.
- History of interstitial lung disease or noninfectious pneumonitis.
- Clinically significant cardio-cerebrovascular disease.
- Severe hypersensitivity to monoclonal antibodies.
- Prior allogeneic stem cell or organ transplantation.
- Need for systemic glucocorticoids (>10 mg/day prednisone or equivalent) or immunosuppressive agents within 14 days before study entry.
- Receipt of live attenuated vaccines within 30 days before first dose.
- Prior exposure to experimental antitumor vaccines or agents targeting immune checkpoint pathways.
- Any condition interfering with drug evaluation or safety interpretation as judged by the investigator.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants receive Cadonilimab by IV infusion every 3 weeks combined with radiotherapy including external beam radiotherapy followed by brachytherapy until disease progression, intolerable toxicity, or up to 2 years.
IV infusion every 3 weeks and radiotherapy sessions as scheduled
Trial Site Locations
Total: 1 location
1
Chongqing university Cancer Hospital
Chongqing, CHN, China, 400000
Actively Recruiting
Research Team
X
Xingtao Long, MD
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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