Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer

Korábbi kezelés

• Diagnosis of other malignancies within 5 years prior to the first dose (excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection).
• Current participation in an interventional clinical study or receipt of other investigational drugs or devices within 4 weeks prior to the first dose.
• Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting other stimulatory or co-inhibitory T-cell receptors .
• Systemic treatment with Chinese herbal medicines with antitumor indications or immunomodulatory agents (e.g., thymosin, interferon, interleukin, excluding local use for pleural effusion control) within 2 weeks prior to the first dose.
• Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal/pituitary insufficiency) are not considered systemic treatment.
• Systemic glucocorticoid therapy (excluding nasal sprays, inhalations, or other local routes) or any immunosuppressive therapy within 7 days prior to the first dose.
• Inadequate recovery from prior intervention-related toxicity or complications (i.e., >Grade 1 or not returned to baseline, excluding fatigue or alopecia).
• Administration of live vaccines within 30 days prior to the first dose (Cycle 1, Day 1).
• Severe or uncontrolled systemic diseases, including:Symptomatic resting Electrocardiograph abnormalities (e.g., complete left bundle branch block, ≥Grade II heart block, ventricular arrhythmia, atrial fibrillation).Unstable angina, congestive heart failure, or chronic heart failure ≥NYHA class II.Arterial thromboembolism, ischemia, myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to enrollment.Poorly controlled hypertension (systolic >140 mmHg, diastolic >90 mmHg).History of non-infectious pneumonitis requiring glucocorticoids within 1 year or current active interstitial lung disease.
• Any condition (e.g., medical history, abnormal lab/test results, concurrent treatments) that may interfere with study outcomes, participation, or pose risks, as judged by the investigator.

Más betegség

• History of allogeneic organ transplantation (excluding corneal transplants) or allogeneic hematopoietic stem cell transplantation.
• Known hypersensitivity to any study drug.
• Presence of multiple factors affecting cisplatin use (e.g., platinum allergy).
• Known history of Human Immunodeficiency Virus（ HIV） infection .
• Untreated active hepatitis B （HBV）(defined as HBsAg-positive with HBV-DNA exceeding the upper limit of normal at the study site).
• Active hepatitisC (HCV) infection (HCV antibody-positive with HCV-RNA above the lower detection limit).
• Active tuberculosis.
• Active or uncontrolled infection requiring systemic therapy.
• Liver diseases (e.g., cirrhosis, decompensated liver disease, acute/chronic active hepatitis).
• Psychiatric disorders impairing compliance.

Laborértékek

• Poorly controlled diabetes (fasting blood glucose >10 mmol/L).

Egyéb

• Pregnant or lactating women.
• Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction.
• Urine protein ≥++ on urinalysis with 24-hour urine protein >1.0 g.

• Female, age ≥18 years;
• Histologically confirmed cervical cancer, FIGO stage IB3, IIA2, IIB, IIIC, and assessed by the researcher as resectable;
• No previous systemic treatment for the current disease, including surgical treatment, antitumor chemoradiotherapy/immunotherapy, etc.;
• Patients who agree to undergo radical surgical treatment and are judged by the surgeon to have no surgical contraindications;
• ECOG score of 0-1;
• Expected survival time >6 months;
• Sufficient organ function, the subject must meet the following laboratory indicators:
  • Neutrophil absolute count (ANC) ≥1.5x10\^9/L ; Platelets ≥100x10\^9/L ;Hemoglobin >9g/dL ; Total bilirubin ≤1.5× upper limit of normal (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN; Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml/min; international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; Normal thyroid function; Myocardial enzymes within the normal range

A regiszterben nem jelölt feltételek

• Histologically confirmed cervical carcinoma, FIGO stage IB3, IIA2, IIB, IIIC1, and assessed as resectable by the researcher。