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

NCT06998394 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-31

No results posted yet for this study

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.

Conditions

  • Cervical Cancer Stage IV

Interventions

DRUG

AK104 - Chemotherapy

AK104 (10mg/kg, q3w) + cisplatin weekly or every 3 weeks + radiotherapy (pelvic external beam radiotherapy + brachytherapy) until disease progression, intolerable toxicity, or the investigator judgment that the participant can no longer benefit, participant withdrawal of consent, or completion of 2 years of AK104 treatment.

Sponsors & Collaborators

  • Xiangbo Wan

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-12
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06998394 on ClinicalTrials.gov