Study on the Efficacy, Safety and Cost-effectiveness of Cadonilimab in the Treatment of Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer
研究概览
简要总结
Cadonilimab, a PD-1/CTLA-4 bi-specific antibody, is being developed by Akeso, Inc. for the treatment of a range of solid tumors, including cervical cancer, lung cancer, gastric/gastroesophageal junction cancer, liver cancer and nasopharyngeal cancer. Cadonilimab was approved in China in June 2022 for use in patients with relapsed or metastatic cervical cancer who have progressed on or after platinum-based chemotherapy. The clinicopathological data of patients with persistent, recurrent or metastatic cervical cancer treated with Cadonilimab were collected, and medical images (magnetic resonance, CT, etc.) before and after treatment were followed up, and the efficacy was evaluated according to RECIST standards. The incidence and severity of adverse events and clinically significant abnormal laboratory test results were collected to evaluate the safety of the drug. Survival benefit analysis is conducted based on the patient's survival time and medical expenses.
详细描述
- To explore the efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer.
The size of each diameter of the tumor before and after treatment was measured on magnetic resonance imaging or CT. Complete response (CR) is defined as the complete disappearance of all target lesions. Partial response (PR): The sum of the diameters of all measurable target lesions is ≥30% below baseline. Disease progression (PD): The minimum value of the sum of the diameters of all measured target lesions during the entire experimental study is used as the reference, and the relative increase in the diameter sum is at least 20% (if the baseline measurement value is the smallest, the baseline value is used as the reference). Stable disease (SD): The reduction of the target lesion does not reach the PR level, and the increase does not reach the PD level, but is somewhere in between. For details, refer to the "Response Evaluation Criteria in Solid Tumors RECIST 1.1. 2. Observation on the safety and adverse reactions of Cadonilimab. Collect adverse events of tumors and abnormal laboratory indicators during medication (nausea, vomiting, bone marrow suppression, liver damage, rash, abnormal thyroid function, adrenocortical dysfunction, diabetes, myocarditis, myositis, hand-foot syndrome, etc.). 3. To explore the cost-benefit analysis of Cadonilimab in patients with cervical cancer. 4. Explore the relationship between genetic mutations and drug efficacy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- ••Persistent, recurrent or metastatic cervical cancer;
- •The pathological types are squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma;
- •No combination with other multiple primary cancers;
- •MRI before treatment Or CT examination, according to RECIST evaluation standards, there is at least one measurable lesion;
- •ECOG score 0-1 points.
- •Subjects gave informed consent, voluntarily cooperated with clinical follow-up, and signed informed consent forms.
排除标准
- •Patients with other histopathological types of cervical cancer, such as small cell carcinoma, clear cell carcinoma, sarcoma, etc.;
- •Previous treatment with immune checkpoint inhibitors;
- •There are drug contraindications, such as liver function Insufficiency, renal insufficiency, etc.
- •The patient withdraws the informed consent;
- •The researcher determines that the patient is not suitable to participate in this clinical study.
研究组 & 干预措施
effective group
The tumor size of each diameter of the tumor before and after treatment was measured on magnetic resonance imaging or CT. According to Recist 1.1 criteria, patients who were evaluated as complete remission, partial remission and stable disease were included in the effective group. Patients assessed as having progressive disease were included in the treatment-refractory group.
干预措施: Cadonilimab (Drug)
ineffective group
The tumor size of each diameter of the tumor before and after treatment was measured on magnetic resonance imaging or CT. According to Recist 1.1 criteria. Patients assessed as having progressive disease were included in the ineffective group.
干预措施: Cadonilimab (Drug)
结局指标
主要结局
Efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer
时间窗: 2026-12-21
Overall survival (OS) was used to evaluate the efficacy of Cadonilimab in the treatment of advanced , recurrent or metastatic cervical cancer.
次要结局
- Safety and adverse reactions of Cadonilimab(2026-12-21)
- cost-effectiveness analysis of using Cadonilimab to treat cervical cancer(2026-12-21)
- The relationship between genetic mutations and the efficacy of Cadonilimab A in patients with cervical cancer(2026-12-21)