Actively Recruiting
A Single-Arm, Phase II Clinical Trail of Cadonilimab Combined With Chemoradiotherapy in Oligometastatic Stage IVB Cervical Cancer
Led by Xiangbo Wan · Updated on 2025-05-31
30
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Single-Arm, Phase II Clinical Trail of Cadonilimab Combined With Chemoradiotherapy in Oligometastatic Stage IVB Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older.
- Able to understand and voluntarily sign informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival of 6 months or more.
- Histologically or cytologically confirmed cervical cancer.
- At least one measurable tumor lesion per RECIST v1.1.
- Willingness to provide tumor tissue samples before enrollment.
- Adequate organ function with specific blood count and chemistry thresholds within 7 days before enrollment.
- Women of childbearing potential must have a negative pregnancy test within 72 hours before treatment and use dual contraception from screening through specified post-treatment periods.
You will not qualify if you...
- Other cervical cancer types such as neuroendocrine carcinoma, small cell carcinoma, sarcoma, or tumors with over 50% non-squamous components.
- History of total hysterectomy removing uterus and cervix; subtotal hysterectomy or cornual resection with cervix preservation is allowed.
- Anatomical issues or tumor shapes preventing brachytherapy.
- Severe bilateral hydronephrosis not relieved by medical procedures.
- Active malignancies within 2 years except certain cured skin and breast cancers.
- Previous treatment with immune checkpoint inhibitors or immunotherapies targeting immune co-stimulation.
- Use of systemic corticosteroids over 10 mg prednisone or immunomodulatory drugs within 2 weeks before enrollment.
- Use of live vaccines within 4 weeks before enrollment.
- Major surgery or significant trauma within 4 weeks before enrollment or planned major surgery during study.
- Active infections needing systemic treatment or active autoimmune diseases except some stable skin or thyroid conditions and type 1 diabetes with stable insulin therapy.
- Known immunodeficiency including positive HIV test.
- History of inflammatory bowel diseases or active diverticulitis.
- History of organ or stem cell transplantation.
- History of interstitial lung disease or non-infectious pneumonia.
- Known severe allergic reactions to monoclonal antibodies.
- Serious cardiovascular events within 6 months including heart attack, unstable angina, blood clots, heart failure NYHA class II or higher, severe arrhythmias needing treatment, recent stroke, left ventricular ejection fraction below 50%, or history of myocarditis or cardiomyopathy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
1 Jianshe East Road, Erqi District, Zhengzhou City, Henan Province
Zhengzhou, Henan, China
Actively Recruiting
Research Team
X
xiao xiao zuo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here