Cervical Cancer
Conditions
Interventions
Experimental group:Enrolled patients will receive Ipaloritumumab 5.0 mg/kg every 3 weeks, with maintenance treatment for 6 months, totaling 8 treatment cycles. Treatment will continue until completion
Sponsors
Affiliated Tumor Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed cervical cancer by pathological histology or cytology, including squamous cell carcinoma, adenosquamous carcinoma, and adenocarcinoma; 2. Patients who have previously undergone radical chemoradiotherapy, have an expected survival of >= 3 months, and are confirmed to have no distant metastasis or recurrence; 3. Three months after completing radical chemoradiotherapy, follow-up MRI or PET-CT imaging suggests residual cervical tumor, and the clinician determines tumor residue based on gynecological examination or tumor markers; or tumor residue is diagnosed through pathological biopsy; 4. Age 18-75 years, KPS score >= 70, weight >= 40 kg; 5. Good function of major organs before treatment: basically normal bone marrow, heart, liver, kidney, thyroid, and nervous system function; 6. Negative pregnancy test within 24 hours prior to first medication (for women of childbearing age only); 7. Will cooperate with regular follow-ups and comply with the study requirements; 8. Signed informed consent for treatment.
Exclusion criteria
Exclusion criteria: 1. Subjects with cervical cancer of other pathological histological types; who have undergone total hysterectomy (removal of uterine body and cervix); 2. Evidence of distant metastasis, including inguinal lymph node metastasis and lymph node metastasis above the upper edge of L1 vertebral body on the cranial side; 3. Subjects who have had other active malignancies within 2 years before randomization, except for locally curable tumors that are considered cured; 4. Subjects who have received other salvage treatments after the completion of radical chemoradiotherapy, including salvage surgery, intravenous chemotherapy, repeat brachytherapy boost, immunotherapy, HIFU treatment, etc.; or have received drugs with immunomodulatory effects within 2 weeks before randomization; 5. Subjects who need systemic treatment with glucocorticoids (>10 mg/day prednisone or equivalent glucocorticoid) or other immunosuppressive drugs within 2 weeks before randomization, except for the following: (1) Inhaled, ophthalmic, or topical glucocorticoids 150 mmHg, diastolic BP >100 mmHg), or history of hypertensive crisis or hypertensive encephalopathy; (2) Myocardial infarction, unstable angina, pulmonary embolism, aortic dissection, deep vein thrombosis, or any arterial thromboembolic events within 6 months before randomization; (3) Heart failure of NYHA classification >= II; (4) Severe arrhythmia requiring long-term medication; asymptomatic, ventricular rate-controlled atrial fibrillation is allowed; (5) Cerebrovascular event (CVA) within 6 months before randomization; (6) Left ventricular ejection fraction (LVEF) <50%; (7) History of myocarditis or cardiomyopathy; 7. Severe infections or major surgery within 4 weeks prior to randomization, or use of live vaccines; or requiring major elective surgery during the study period; 8. Having active or potentially recurrent autoimmune diseases; presence of active infections requiring systemic treatment; 9. History of other serious conditions, such as active or documented inflammatory bowel disease, active diverticulitis; history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, history of interstitial lung disease or non-infectious pneumonia, history of severe hypersensitivity to other monoclonal antibodies; 10. Any contraindication to epalrezumab or history of severe allergic reactions to it; 11. Pregnant or breastfeeding women; 12. Any condition that the investigator believes may pose a risk to receiving the study drug, interfere with the assessment of the study drug, or affect the safety of the participant or the interpretation of study results (e.g., other serious illnesses or psychiatric disorders).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year and 5-year progression-free survival rates (PFS);3-year and 5-year overall survival (OS);The Relationship Between Biomarkers, Tumor Mutational Burden (TMB), and the Efficacy of Immunotherapy;Safety and tolerability; | — |
Countries
China
Contacts
Public ContactMingyi Li
Affiliated Tumor Hospital of Guangzhou Medical University
Outcome results
None listed