Cervical Cancer Stage IVPhase 2NCT06998394
A Single-Arm, Phase II Clinical Trail of Cadonilimab Combined With Chemoradiotherapy in Oligometastatic Stage IVB Cervical Cancer
A Phase 2 study testing AK104 - Chemotherapy in people with Cervical Cancer Stage IV, run by Xiangbo Wan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer Stage IV
- What is being tested?
- AK104 - Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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, superficial bladder cancer, and breast carcinoma in situ.
- 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 diagnostic purposes is allowed.
- 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 requiring only stable hormone replacement therapy; type 1 diabetes requiring only stable insulin replacement therapy.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
1 Jianshe East Road, Erqi District, Zhengzhou City, Henan Province
Zhengzhou, Henan
xiaoxiao zuo, 13526513796, fcczuoxx@zzu.edu.cn
About this study
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
- Being tested
- AK104 - Chemotherapy
- Keywords
- Cadonilimab, Cervical Cancer, Oligometastasis, Individualized Radiotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK104 - ChemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| AK104 | Experimental | Not described Receives: Drug: AK104 - Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-3-year progression-free survival
Measured: From enrollment to 3 years after the end of treatment
Secondary outcomes (3)
Objective response rate
Measured: at least 12 weeks
Disease control rate
Measured: at least 12 weeks
Overall survival
Measured: From date of randomization until the date of death，assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start12 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangbo Wan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiangbo Wan, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998394
- Sponsor's protocol ID
- 2024-KY-1629-003
- Status last verified
- May 2025
- First submitted
- 5 Mar 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Phase II Clinical Trail of Cadonilimab Combined With Chemoradiotherapy in Oligometastatic Stage IVB Cervical Cancer
- ClinicalTrials.gov ID
- NCT06998394
- Acronym / sponsor ID
- 2024-KY-1629-003
- Conditions
- Cervical Cancer Stage IV
- Keywords
- Cadonilimab, Cervical Cancer, Oligometastasis, Individualized Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xiangbo WanUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK104 | Experimental | Drug: AK104 - Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (28 listed)
- Histopathological Exclusions
- Orange State Exclusions
- 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.
- Therapeutic Exposure
- Concomitant Disease Exposure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK104 - ChemotherapyAK104 (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. | Drug | AK104 |
Primary outcome
1-3-year progression-free survival
Time frame: From enrollment to 3 years after the end of treatment
3 secondary outcomes
Objective response rate
Time frame: at least 12 weeks
Disease control rate
Time frame: at least 12 weeks
Overall survival
Time frame: From date of randomization until the date of death，assessed up to 100 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK104 - Chemotherapy in people with Cervical Cancer Stage IV, run by Xiangbo Wan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiao xiao zuo (13526513796, fcczuoxx@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-3-year progression-free survival (time frame: From enrollment to 3 years after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.