NCT06998394 A Single-Arm, Phase II Clinical Trail of Cadonilimab Combined With Chemoradiotherapy in Oligometastatic Stage IVB Cervical Cancer

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Brief Summary

Cervical cancer is one of the most malignant reproductive system tumors that threaten women's health, characterized by distinct HPV-driven carcinogenesis and immunosuppressive tumor microenvironment. According to statistics from the World Health Organization (WHO) and the GLOBOCAN database, there were approximately 604,127 new cases of cervical cancer worldwide in 2022, with about 341,831 deaths, accounting for 6.5% of all female cancer-related deaths. While HPV vaccines can effectively reduce the incidence of cervical cancer, which has demonstrated 90% efficacy in preventing HPV16/18-associated malignancies, the global incidence and mortality rates of cervical cancer have not shown a significant downward trend. Cervical cancer also has a high recurrence rate, with approximately 30% of intermediate and advanced cervical cancer cases recurring within 5 years, and the 5-year survival rate for high-risk patients after recurrence is less than 20%. It is evident that cervical cancer remains a serious threat to women's health. Current research has confirmed that more than 90% of cervical cancer cases are associated with persistent infection with high-risk HPV viruses. HPV-positive status is positively correlated with increased PD-L1 expression, and PD-L1 expression in cervical cancer tissues is closely related to the proliferation and activation of CD8+ T cells. Preclinical models demonstrate that dual checkpoint blockade PD-1/CTLA-4 inhibition synergistically enhances CD8+ T cell activation and tumor regression in HPV+ cervical cancer xenografts. Therefore, cervical cancer patients are likely to benefit from immunotherapy. Based on the unmet treatment needs of cervical cancer and its high immune response, immunotherapy for cervical cancer has become a focus of attention in the field of gynecological oncology in recent years. The pharmacokinetics, and immunogenicity characteristics of this regimen, provide an effective treatment option to further improve the survival of advanced cervical cancer patients. Based on the above research background, this study targets stage IVB cervical cancer with oligometastasis. In addition to systemic chemotherapy combined with individualized radiotherapy, cadonilimab, one bispecific antibody for PD-1/CTLA-4, is added to explore the preliminary anti-tumor activity, safety, pharmacokinetics, and immunogenicity characteristics of this regimen, providing an effective treatment option to further improve the survival of advanced cervical cancer patients.

Eligibility Criteria

Inclusion Criteria: 1. Informed Consent Capacity Participants must be able to understand and voluntarily sign a written informed consent form. The informed consent form must be duly signed before any study-specific procedures are performed. 2. Demographic Parameters Female participants aged ≥ 18 years on the day of signing the informed consent form. 3. Functional Status Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 4. Prognostic Threshold Expected survival ≥ 6 months. 5. Diagnostic Confirmation Histologically or cytologically confirmed cervical cancer. 6. Lesion Quantification At least one measurable tumor lesion according to RECIST v1.1 criteria. 7. Biomarker Accessibility All participants must be willing to provide tumor tissue samples before enrollment. 8. Organ Functional Reserve Screening laboratory values meeting the following thresholds (performed within 7 days prior to enrollment): 1. Hematopoietic: ANC ≥1.5×10⁹/L; Platelets ≥100×10⁹/L; Hemoglobi

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