Iparomlimab and Tuvonralimab Combined With Platinum-Based Chemotherapy for Neoadjuvant Treatment of Cervical Cancer

Exclusion Criteria

• •Histopathological type other than cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (e.g., small cell carcinoma, clear cell carcinoma, sarcoma).
• •History of other malignancies within 3 years prior to enrollment, excluding localized malignancies cured by local therapy (e.g., basal cell carcinoma, squamous cell carcinoma of the skin, or ductal carcinoma in situ of the breast).
• •Simultaneous enrollment in another clinical study, unless it is an observational, non-interventional study or within the follow-up period of an interventional study.
• •Non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, tumor necrosis factor) within 2 weeks prior to first dose; herbal or proprietary Chinese medicine with antitumor indications within 1 week prior to first dose.
• •Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, immunosuppressants) within the past 2 years. Replacement therapy (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal/pituitary insufficiency) is not considered systemic therapy.
• •History of non-infectious pneumonia requiring systemic corticosteroids or current interstitial lung disease.
• •Significant bleeding diathesis or coagulation dysfunction.
• •Uncontrolled comorbidities, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease/gastritis, or psychiatric/social conditions impairing compliance or informed consent.
• •History of myocarditis, cardiomyopathy, or malignant arrhythmias. Within 12 months prior to first dose: unstable angina, congestive heart failure, or vascular disease requiring hospitalization (e.g., surgical repair of aortic aneurysm/peripheral venous thrombosis). Within 6 months prior: esophageal-gastric varices, unhealed wounds, gastrointestinal perforation, fistula, obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding. Arterial thromboembolism, NCI CTCAE 5.0 grade ≥3 venous thromboembolism, transient ischemic attack, stroke, hypertensive crisis, or hypertensive encephalopathy. Within 1 month prior: acute exacerbation of COPD. Current hypertension uncontrolled with oral antihypertensives (SBP ≥160 mmHg or DBP ≥100 mmHg).
• •Active or history of definite inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).
• •Severe infection within 4 weeks prior to first dose (including hospitalization, sepsis, or severe pneumonia). Active infection requiring systemic antimicrobial therapy within 10 days prior (excluding HBV/HCV antiviral therapy).
• •Major surgery or severe trauma within 30 days prior to first dose; minor local procedures (excluding peripherally inserted central catheter placement) within 3 days prior.
• •History of immunodeficiency, HIV seropositivity, or current long-term systemic corticosteroid/immunosuppressant use.
• •Active pulmonary tuberculosis (TB) or suspected TB requiring clinical exclusion (e.g., sputum AFB, chest X-ray).
• •Active syphilis infection.
• •History of allogeneic organ or hematopoietic stem cell transplantation.
• •Untreated active HBV (HBsAg+ with HBV-DNA \>1000 copies/mL \[200 IU/mL\] or above limit of detection). HBV patients must receive antiviral therapy during study. Active HCV (HCV Ab+ with HCV-RNA above limit of detection).
• •Live vaccine administration within 30 days prior to first dose or planned during study.
• •Known hypersensitivity to any study drug component or severe allergic reaction to other monoclonal antibodies.
• •History of psychiatric disorders, substance abuse, alcoholism, or drug addiction.
• •Pregnancy or lactation.
• •Any disease, treatment, or laboratory abnormality that may confound study results, hinder compliance, or compromise participant safety.