Suffering from locally advanced (FIGO 2018 IB3, IIA2, IIB stage)
Conditions
Interventions
Experimental group:Intravenous infusion of Epalreltoverli monoclonal antibody injection
Sponsors
The Central Hospital of Wuhan
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The participant voluntarily participates and signs the informed consent form; 2. Age >=18 years at the time of signing the informed consent form; 3.Diagnosis of locally advanced cervical cancer (FIGO 2018 stage IB3, IIA2, or IIB) without prior systemic therapy; or diagnosis of recurrent/metastatic cervical cancer without prior systemic therapy for this stage and not suitable for radical treatment with surgery and/or radiotherapy; 4.According to RECIST 1.1 criteria, the participant must have at least one measurable target lesion assessed by CT or MRI; 5.All participants must provide archived or freshly obtained tumor tissue samples from within 2 years prior to the first dose (or up to 5 years, if approved by the medical monitor), approximately 5–15 unstained FFPE pathological slides (preferably from recently acquired tumor tissue), stored at -80°C for detection of PD-L1 expression and other biomarkers. Additionally, 6–10 mL of whole blood must be collected prior to each treatment cycle for biomarker analysis in blood, also stored at -80°C; 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1; 7. Expected survival >=3 months; 8. Within 7 days prior to the first dose, organ function must meet the following criteria (no supportive therapy such as blood products or growth factors is allowed within 14 days prior to the first dose): (1) Absolute neutrophil count >=1.5×10^9/L.;(2) Platelets =100×10^9/L;(3) Hemoglobin >=90 g/L;(4) Serum albumin >=30 g/L;(5) AST and ALT 1.5×ULN, creatinine clearance (CLcr) calculated using the Cockcroft-Gault equation must be >=50 mL/min;(8) Left ventricular ejection fraction (LVEF) >50%;(9) Proteinuria =2+, a 24-hour urine protein quantification is required; participants with <=1 g are eligible);(10). International normalized ratio (INR) <=1.5; activated partial thromboplastin time (APTT) <=1.5×ULN. 9.Prior to the first dose, any adverse events (AEs) related to previous anti-tumor therapy must have recovered (i.e., <= Grade 1 per CTCAE v5.0), excluding alopecia (any grade) and peripheral sensory neuropathy, hypomagnesemia, or lymphocytopenia of <= Grade 2, as well as other abnormalities that, in the opinion of the investigator and/or sponsor, pose acceptable risk to the participant given the potential treatment benefit; 10.The participant agrees to use effective contraception from the time of signing the informed consent until 180 days after the last dose. Female participants of childbearing potential must not be pregnant or breastfeeding.
Exclusion criteria
Exclusion criteria: 1. Completion of radical concurrent chemoradiotherapy or adjuvant chemoradiotherapy less than 3 months (90 days) prior to the first dose, or completion of palliative radiotherapy (e.g., for pain or bleeding) less than 2 weeks prior to the first dose; 2.Prior use of chemotherapy other than for the purpose of initial curative treatment (Note: Concurrent chemoradiotherapy, neoadjuvant or consolidation chemotherapy cycles prior to radiotherapy, or up to 2 cycles of chemotherapy after completion of chemoradiotherapy are allowed); 3. Prior immunotherapy, including immune checkpoint inhibitor antibodies (e.g., anti-PD-1, PD-L1, CTLA-4 antibodies, etc.), immune checkpoint agonist antibodies (e.g., anti-ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), and immune cell therapy; prior treatment with VEGF/VEGFR inhibitors, such as bevacizumab, ramucirumab, aflibercept, and tyrosine kinase inhibitors, etc. 4.Use of aspirin (>325 mg/day), clopidogrel (>75 mg/day), dipyridamole, ticlopidine, cilostazol, or other therapeutic anticoagulation (except low molecular weight heparin) within 2 weeks prior to the first dose; 5. Systemic infection requiring intravenous antibiotics for >7 days within 2 weeks prior to the first dose, or other severe infection, or unexplained fever >38.5°C during screening or before enrollment (unless judged by the investigator to be due to the tumor); 6. Requirement for systemic corticosteroid (>10 mg prednisone daily or equivalent) or other immunosuppressive drugs (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-a inhibitors, etc.) within 2 weeks prior to the first dose. Topical, intranasal, and inhaled corticosteroids are allowed. Prophylactic use of systemic corticosteroids for contrast allergy is permitted. 7.Systemic treatment with Chinese patent medicines with anti-tumor indications, Chinese herbal medicines with anti-tumor effects, or immunomodulatory drugs (e.g., thymosin, interferon, interleukin, etc.) within 2 weeks prior to the first dose; 8.Major surgery, open biopsy, or significant trauma within 4 weeks prior to the first dose; or planned elective major surgery during the study period; 9.Symptomatic central nervous system (CNS) metastases, leptomeningeal metastases, or spinal cord compression prior to signing the informed consent. Asymptomatic participants with stable disease (clinically and/or radiographically), off corticosteroids and anticonvulsants for at least 2 weeks, and not requiring further treatment (radiotherapy, surgical resection, and/or corticosteroid therapy) are eligible; 10. Currently clinically significant hydronephrosis not amenable to relief via nephrostomy or ureteral stenting, as judged by the investigator; 11.Currently uncontrolled third-space effusions requiring repeated drainage or other local interventions; 12. Active or potentially recurrent autoimmune diseases, except for: vitiligo, alopecia, psoriasis, or eczema not requiring systemic therapy; hypothyroidism due to autoimmune thyroiditis requiring only stable-dose hormone replacement; type I diabetes requiring only stable-dose insulin replacement; 13.History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose; history of intestinal obstruction (participants with initial incomplete/obstructive symptoms/signs who received treatment and symptoms resolved may be enrolled per investigator's assessment); extensive intestinal resection (partial colectomy or extensive small bowel resection wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactXun Tian
The Central Hospital of Wuhan
Outcome results
None listed