uterine cervical cancer
Conditions
Interventions
Experimental group:Iparomlimab and Tuvonralimab
Sponsors
Hubei Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Prior to the initiation of any trial procedures, the informed consent form must be obtained and filed at the study center. 2.Female patients aged >=18 years and = 1.5 ×10^9/L (1,500/mm^3); 2) Platelet count >= 100 × 10^9/L (100,000/mm^3); 3) Hemoglobin >= 90 g/L. (2) Kidneys: 1) Creatinine clearance* (CrCl) calculated value >= 50 mL/min. The CrCl will be calculated using the Cockcroft-Gault formula: CrCl (mL/min) = {(140 - age) × weight (kg) × 0.85}/(serum creatinine (mg/dL) × 72); 2) Urine protein = 28 g/L; 3) Coagulation: International Normalized Ratio (INR) and activated partial thromboplastin time (APTT) = 50%. 9. No history of using immune checkpoint inhibitors; 10. Female participants of childbearing potential must have a urine or serum pregnancy test within 3 days before the first dose of the study drug (if the urine pregnancy test cannot confirm a negative result, a serum pregnancy test must be done, and the serum result will be considered definitive), and the result must be negative. If a female participant of childbearing potential has sexual intercourse with a non-sterilized male partner, she must use an acceptable highly effective contraceptive method from the start of screening and agree to continue using it for 120 days after the last dose of the study drug; whether to stop contraception after this period should be discussed with the researcher. Periodic abstinence or the rhythm method is not acceptable as contraception. (1) Women of childbearing potential are defined as females who have not undergone surgical sterilization (i.e., bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy) or are not menopausal (menopause is defined as at least 12 consecutive months of amenorrhea without medical treatment, with serum follicle-stimulating hormone levels within the postmenopausal laboratory reference range); (2) Highly effective contraceptive methods are those with a very low failure rate (e.g., less than 1% per year) when used consistently and correctly. Not all contraceptives are highly eff
Exclusion criteria
Exclusion criteria: 1.Personnel involved in the planning or implementation of the study. 2.Previous treatment with dual-specific anti-PD-1/PD-L1 and anti-CTLA-4 therapy, or drugs that co-inhibit T cell receptors (e.g., OX-40, CD137). 3.Known allergy to the active ingredient or excipients of Aparlimab Torivalimab. 4.Symptomatic or uncontrolled brain metastases requiring concurrent treatment, including but not limited to surgery, radiation therapy, and/or corticosteroids, or with clinical manifestations of spinal cord compression. 5.Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose. 6.Diagnosis of other malignant diseases besides cervical cancer within 5 years prior to the first dose (excluding cured basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and/or carcinoma in situ that has been radically resected). 7.Active autoimmune diseases requiring systemic treatment (e.g., use of disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment; Note: Patients with cataracts, Graves' disease, or psoriasis that did not require systemic treatment (within the past 2 years) are not excluded. 8.Active hemoptysis within 3 months prior to the first dose (expectoration of at least 2.5 mL or 1/2 teaspoon of bright red blood per episode). 9.Received a live vaccine within 1 month prior to the first dose; Note: Inactivated seasonal influenza vaccines administered as injections within 30 days prior to the first dose are allowed; however, intranasal live attenuated influenza vaccines are not permitted. 10.Received platelet or red blood cell transfusions within 2 weeks prior to the first dose, excluding patients with active cervical bleeding. 11.Received major surgical treatment (excluding biopsy procedures) within 4 weeks prior to the first dose, or planned to undergo major surgery during the study period. 12.Received traditional Chinese medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukins, except for local use to control pleural effusion) for systemic treatment within 2 weeks prior to the first dose. 13.Systemic corticosteroid therapy (excluding nasal spray, inhaled, or other routes of local corticosteroids) or any other form of immunosuppressive therapy (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 7 days prior to the first dose; Note: Physiological doses of corticosteroids (= 10 mg/day of prednisone or equivalent) are permitted. 14.Presence of clinically uncontrolled pleural effusion/ascites (patients who do not require drainage or have no significant increase in effusion after stopping drainage for 3 days are eligible for inclusion). 15.Severe unhealed wounds, ulcers, or fractures. 16.Known history of solid organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation. 17.Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive). 18.Untreated active hepatitis B (defined as HBsAg-positive with concurrent HBV-DNA copy number exceeding the upper limit of normal of the study center's laboratory);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;ORR of neoadjuvant therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug safety; | — |
Countries
China
Contacts
Public ContactYi Huang
Hubei Cancer Hospital
Outcome results
None listed