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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

A Single-Arm, Phase II Clinical Trail of Cadonilimab Combined With Chemoradiotherapy in Oligometastatic Stage IVB Cervical Cancer (NCT06998394) is a Phase 2 interventional studying Cervical Cancer Stage IV, sponsored by Xiangbo Wan. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Cervical Cancer Stage IV and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. willing to sign a consent form Capacity Participants must be able to understand and voluntarily sign a written willing to sign a consent form form. The willing to sign a consent form 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 willing to sign a consent form 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 diagnosed by tissue sample (biopsy-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: white blood cell count (ANC) at least 1.5×10⁹/L; platelet count at least 100×10⁹/L; blood count (hemoglobin) at least 9 g/dL. 2. Hepatic: Total bilirubin ≤1.5×ULN; AST/ALT ≤2.5×ULN. 3. Renal: Serum creatinine ≤1.5×ULN OR calculated CrCl ≥60 mL/min (Cockcroft-Gault). 9. Reproductive Safety Women of childbearing potential (WOCBP) must: 1. Demonstrate negative serum β-hCG pregnancy test within 72 hours prior to treatment initiation. 2. Utilize dual contraceptive methods (e.g., oral contraceptives + barrier device) from screening through ≥120 days post-final dose and ≥180 days post-chemoradiation. 3. Abst requiresinence declaration medical confirmation non of-reproductive status. Who Should NOT Join This Trial: 1. Histopathological Exclusions 1. Participants with other histological types of cervical cancer, such as neuroendocrine carcinoma, small cell carcinoma, sarcoma, etc. 2. Mixed epithelial-mesenchymal tumors with \>50% non-squamous component. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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; Hemoglobin ≥9 g/dL. 2. Hepatic: Total bilirubin ≤1.5×ULN; AST/ALT ≤2.5×ULN. 3. Renal: Serum creatinine ≤1.5×ULN OR calculated CrCl ≥60 mL/min (Cockcroft-Gault). 9. Reproductive Safety Women of childbearing potential (WOCBP) must: 1. Demonstrate negative serum β-hCG pregnancy test within 72 hours prior to treatment initiation. 2. Utilize dual contraceptive methods (e.g., oral contraceptives + barrier device) from screening through ≥120 days post-final dose and ≥180 days post-chemoradiation. 3. Abst requiresinence declaration medical confirmation non of-reproductive status. Exclusion Criteria: 1. Histopathological Exclusions 1. Participants with other histological types of cervical cancer, such as neuroendocrine carcinoma, small cell carcinoma, sarcoma, etc. 2. Mixed epithelial-mesenchymal tumors with \>50% non-squamous component. 2. Orange State Exclusions 1. History of total hysterectomy (removal of the uterine body and cervix). Subtotal hysterectomy or cornual resection with preservation of the cervix is allowed. 2. Anatomical abnormalities or tumor geometry-related contraindications that prevent the use of brachytherapy. 3. Clinically significant bilateral hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting, as judged by the investigator. 3. 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, superficial bladder cancer, and breast carcinoma in situ. 4. Therapeutic Exposure 1. Previous treatment with immune checkpoint inhibitors or any tumor immunotherapy targeting immune co-stimulatory factors. 2. Use of systemic corticosteroids (\> 10 mg/day prednisone or equivalent doses of corticosteroids) or other immunomodulatory drugs within 2 weeks before enrollment. 3. Use of live vaccines within 4 weeks before enrollment. 4. 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 diagnostic purposes is allowed. 5. Concomitant Disease Exposure 1. 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 requiring only stable hormone replacement therapy; type 1 diabetes requiring only stable insulin replacement therapy. 2. Known primary or secondary immunodeficiency, including positive human immunodeficiency virus (HIV) antibody test. 3. Active or documented history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), active diverticulitis. 6. Past Medical History Exposure 1. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 2. Known history of interstitial lung disease or non-infectious pneumonia. 3. Known history of severe hypersensitivity to monoclonal antibodies. 7. Cardiovascular Diseases Exposure 1. Myocardial infarction, unstable angina, pulmonary embolism, aortic dissection, deep vein thrombosis, or any arterial thromboembolic event within 6 months before enrollment. 2. Heart failure with New York Heart Association (NYHA) class ≥ II. 3. Severe arrhythmias requiring long-term drug intervention; asymptomatic atrial fibrillation with stable ventricular rate is allowed. 4. Cerebrovascular events (CVA) within 6 months before enrollment. 5. Left ventricular ejection fraction (LVEF) \< 50%. 6. History of myocarditis or cardiomyopathy.

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

1 Jianshe East Road, Erqi District, Zhengzhou City, Henan Province
Zhengzhou, Henan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06998394), the sponsor (Xiangbo Wan), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06998394 clinical trial studying?

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-associat… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06998394?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06998394?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06998394. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06998394. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.