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New treatment option for Cervical Cancer Stage IV
Official title A Single-Arm, Phase II Clinical Trail of Cadonilimab Combined With Chemoradiotherapy in Oligometastatic Stage IVB Cervical Cancer
ClinicalTrials.gov ID: NCT06998394
What this study is testing
What is AK104 - Chemotherapy?
AK104 - Chemotherapy is an investigational medicine, given as an once-weekly, being studied as a potential treatment for cervical cancer stage iv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Informed Consent Capacity Participants must be able to understand and voluntarily sign a written informed consent form. The informed consent form...
- Demographic Parameters Female participants aged ≥ 18 years on the day of signing the informed consent form.
- Functional Status Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Prognostic Threshold Expected survival ≥ 6 months.
- Diagnostic Confirmation Histologically or cytologically confirmed cervical cancer.
You likely can't join if
- Histopathological Exclusions
- Participants with other histological types of cervical cancer, such as neuroendocrine carcinoma, small cell carcinoma, sarcoma, etc.
- Mixed epithelial-mesenchymal tumors with \>50% non-squamous component.
- Orange State Exclusions
- History of total hysterectomy (removal of the uterine body and cervix). Subtotal hysterectomy or cornual resection with preservation of the cervix is...
- Anatomical abnormalities or tumor geometry-related contraindications that prevent the use of brachytherapy.
See the full eligibility criteria
- 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.
- Demographic Parameters Female participants aged ≥ 18 years on the day of signing the informed consent form.
- Functional Status Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Prognostic Threshold Expected survival ≥ 6 months.
- Diagnostic Confirmation Histologically or cytologically confirmed cervical cancer.
- Lesion Quantification At least one measurable tumor lesion according to RECIST v1.1 criteria.
- Biomarker Accessibility All participants must be willing to provide tumor tissue samples before enrollment.
- Organ Functional Reserve Screening laboratory values meeting the following thresholds (performed within 7 days prior to enrollment):
- Hematopoietic: ANC ≥1.5×10⁹/L; Platelets ≥100×10⁹/L; Hemoglobin ≥9 g/dL.
- Hepatic: Total bilirubin ≤1.5×ULN; AST/ALT ≤2.5×ULN.
- Renal: Serum creatinine ≤1.5×ULN OR calculated CrCl ≥60 mL/min (Cockcroft-Gault).
- Reproductive Safety Women of childbearing potential (WOCBP) must:
- Demonstrate negative serum β-hCG pregnancy test within 72 hours prior to treatment initiation.
- Utilize dual contraceptive methods (e.g., oral contraceptives + barrier device) from screening through ≥120 days post-final dose and ≥180 days post-chemoradiation.
- Abst requiresinence declaration medical confirmation non of-reproductive status.
- Histopathological Exclusions
- Participants with other histological types of cervical cancer, such as neuroendocrine carcinoma, small cell carcinoma, sarcoma, etc.
- Mixed epithelial-mesenchymal tumors with \>50% non-squamous component.
- Orange State Exclusions
- History of total hysterectomy (removal of the uterine body and cervix). Subtotal hysterectomy or cornual resection with preservation of the cervix is allowed.
- Anatomical abnormalities or tumor geometry-related contraindications that prevent the use of brachytherapy.
- Clinically significant bilateral hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting, as judged by the investigator.
- Oncological History Other active malignancies within 2 years before enrollment, except for locally curable cancers that have been cured, such as squamous cell carcinoma of the skin, basal cell carcinoma of the skin...
- Therapeutic Exposure
- Previous treatment with immune checkpoint inhibitors or any tumor immunotherapy targeting immune co-stimulatory factors.
- Use of systemic corticosteroids (\> 10 mg/day prednisone or equivalent doses of corticosteroids) or other immunomodulatory drugs within 2 weeks before enrollment.
- Use of live vaccines within 4 weeks before enrollment.
- Major surgery within 4 weeks before enrollment (as determined by the investigator), open biopsy, or significant trauma; or planned major surgery during the study. Systemic pelvic/para-aortic lymphadenectomy for...
- Concomitant Disease Exposure
- Active infections requiring systemic treatment, or active autoimmune diseases, except for vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism caused by autoimmune thyroiditis...
- Known primary or secondary immunodeficiency, including positive human immunodeficiency virus (HIV) antibody test.
- Active or documented history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), active diverticulitis.
- Past Medical History Exposure
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known history of interstitial lung disease or non-infectious pneumonia.
- Known history of severe hypersensitivity to monoclonal antibodies.
- Cardiovascular Diseases Exposure
- Myocardial infarction, unstable angina, pulmonary embolism, aortic dissection, deep vein thrombosis, or any arterial thromboembolic event within 6 months before enrollment.
- Heart failure with New York Heart Association (NYHA) class ≥ II.
- Severe arrhythmias requiring long-term drug intervention; asymptomatic atrial fibrillation with stable ventricular rate is allowed.
- Cerebrovascular events (CVA) within 6 months before enrollment.
- Left ventricular ejection fraction (LVEF) \< 50%.
- History of myocarditis or cardiomyopathy.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.