The goal of this clinical trial is to evaluate the safety and effectiveness of AK104 (Cadonilimab) combined with chemotherapy (cisplatin or carboplatin, and etoposide) for the treatment of recurrent or metastatic small cell neuroendocrine carcinoma of the cervix. The main questions it aims to answer are: Is AK104 (Cadonilimab) combined with chemotherapy effective in treating recurrent or metastatic small cell neuroendocrine carcinoma of the cervix? What side effects or medical issues do participants experience while taking AK104? Participants will: Receive AK104 (10 mg/kg) combined with either cisplatin (75 mg/m²) or carboplatin (AUC 5) and etoposide (100 mg/m²) every three weeks for up to six cycles. After chemotherapy, continue with AK104 (10 mg/kg every three weeks) until disease progression, intolerable toxicity, investigator decision, withdrawal of consent, death, or other reasons specified in the protocol, with a maximum treatment duration of 24 months. Undergo tumor assessments every 6 weeks (±7 days) for the first 48 weeks after the first dose, and every 12 weeks (±7 days) thereafter. Participants who discontinue treatment for reasons other than disease progression will continue with follow-up for disease status as much as possible, until they begin another anticancer therapy, experience disease progression, withdraw consent, die, or the study ends, whichever occurs first. Researchers will evaluate the safety of AK104 by assessing adverse events (AEs) using the NCI CTCAE version 5.0 grading system, and determine their relationship to the drug. Depending on the severity of the AEs and their relationship to the drug, researchers will take appropriate measures and provide additional treatments to ensure participant safety. After completing treatment, participants will have a safety follow-up visit (90 days after the last dose) and then participate in survival follow-up every 3 months to collect survival information and information on subsequent anticancer treatments until death, withdrawal of consent, or the end of the study, whichever occurs first.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
Eligible Ages | 18 Years - 75 Years |
Gender | Female |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT06810895 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Ding Ma |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Enrolling by invitation |
Countries | China |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Cervix Cancer, Cadonilimab, Small Cell Neuroendocrine Carcinoma of the Cervix |
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