Cadonilimab with chemoradiotherapy for oligometastatic Stage IVB cervical cancer

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

This trial will test whether adding cadonilimab to chemoradiotherapy helps women with oligometastatic Stage IVB cervical cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: The First Affiliated Hospital of Zhengzhou University (other)
• Drugs / interventions: immunotherapy, prednisone, cadonilimab, chemotherapy
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06998394 on ClinicalTrials.gov

What this trial studies

This single-arm Phase II trial gives cadonilimab (AK104) combined with chemotherapy and individualized radiotherapy to women with oligometastatic Stage IVB cervical cancer. Eligible participants must be adults with histologically confirmed disease, ECOG performance status 0–1, at least one measurable lesion per RECIST v1.1, and willing to provide tumor tissue. The regimen pairs a bispecific immune checkpoint inhibitor with standard chemoradiotherapy and local ablative treatment to metastatic sites, with patients followed for tumor response, progression-free survival, and safety. Treatment-related adverse events and organ function will be closely monitored throughout the study.

Who should consider this trial

Good fit: Women aged 18 or older with histologically confirmed oligometastatic Stage IVB cervical cancer, ECOG 0–1, at least one measurable lesion, expected survival ≥6 months, and willing to provide tumor tissue are ideal candidates.

Not a fit: Patients with poor organ function, ECOG performance status ≥2, widespread non-oligometastatic disease, or who cannot tolerate immunotherapy, chemotherapy, or radiotherapy are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could improve tumor control and extend survival for women with oligometastatic Stage IVB cervical cancer.

How similar studies have performed: Combining immune checkpoint inhibitors with chemoradiotherapy has shown promising signals in cervical and other cancers, but cadonilimab in this specific oligometastatic setting is still early-stage.

Eligibility criteria

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.

Where this trial is running

Zhengzhou, Henan

• 1 Jianshe East Road, Erqi District, Zhengzhou City, Henan Province — Zhengzhou, Henan, China (RECRUITING)

Study contacts

• Study coordinator: xiao xiao zuo

Conditions: Cervical Cancer Stage IV, Cadonilimab, Cervical Cancer, Oligometastasis, Individualized Radiotherapy