Cervical Cancer Clinical Trial
Official title:
Study on the Efficacy, Safety and Cost-effectiveness of Cadonilimab in the Treatment of Cervical Cancer
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.
1. 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. ;
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