locally advanced cervical cancer
Conditions
Interventions
Aipaluolituoweirimu (proposed transliteration) + Nab-paclitaxel + Cisplatin:260 mg/m2 administered intravenously over 30 minutes on Day 1
Cisplatin 75 mg/m2 administered intravenously. If cisplatin is not tolerated, carboplatin (AUC 5, intravenous infusion on Day 1) may be used as an alternative.
Aipalituotuo Weirili Monoclonal Antibod
Sponsors
The First Affiliated Hospital of Airforce Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged between 18 and 70 years (inclusive);? 2. Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;? 3. Previously untreated IB3 or IIA2 stage cervical cancer according to the FIGO 2018 staging system;? 4. At least one measurable lesion based on RECIST version 1.1 criteria, with MRI-confirmed lymph node diameter less than 1.5 cm; 5.?Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;?6.Patients must provide tumor tissue samples for PD-L1 expression testing, either formalin-fixed paraffin-embedded (FFPE) or fresh tumor tissue; 7.?Laboratory test requirements:? a. Hematology (no blood transfusion, hematopoietic growth factors, or other medications affecting blood counts within 14 days): absolute neutrophil count (ANC) >= 1.5×10?/L; platelet count (PLT) >= 80×10?/L; hemoglobin (HGB) >= 90 g/L;? b. Biochemistry: serum creatinine = 60 mL/min calculated using the Cockcroft-Gault formula if >1.5 × ULN; total bilirubin (TBIL) <= 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels within acceptable range. 8. Female subjects of childbearing potential must have a negative pregnancy test, not be breastfeeding, and must agree to use effective medical contraception from the time of informed consent signing until six months after the last study drug administration; 9. Subjects must voluntarily participate in the study, demonstrate good compliance with planned treatment and follow-up procedures, and be able to understand the study process and willingly sign the informed consent form
Exclusion criteria
Exclusion criteria: 1.Presence of distant metastatic disease;? 2.Prior receipt of any anti-cancer therapy, including but not limited to surgery (excluding biopsy), radiation therapy, or systemic treatments such as chemotherapy, immunotherapy, or targeted therapy; 3.?Previous treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 or anti-PD-L1 antibodies;? 4.Active malignancy within three years prior to first dosing, except for cervical cancer under investigation in this trial or any localized, curable tumors that have received definitive treatment (e.g., completely resected basal cell or squamous cell skin cancer, superficial bladder cancer, or cured in situ cancers such as breast carcinoma in situ);? 5.Active autoimmune disease, or history of autoimmune disease within two years before enrollment requiring ongoing systemic treatment. Autoimmune diseases include but are not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, or asthma requiring bronchodilator intervention. However, participants with well-controlled type I diabetes, hypothyroidism managed solely with hormone replacement therapy, non-systemically treated skin conditions (such as vitiligo, psoriasis, or alopecia), or those whose condition is unlikely to recur without external triggers may still be considered for enrollment;? 6.Primary immunodeficiency disorder or relevant medical history;? 7.Received immunosuppressive agents (e.g., cyclosporine) within 14 days prior to enrollment or require daily systemic corticosteroid use (e.g., >20 mg/day prednisone or equivalent), except for nasal sprays, inhalers, or other forms of localized steroid therapy;?8.Positive for human immunodeficiency virus antibody (HIV-Ab) or active syphilis infection; positive for hepatitis B surface antigen (HBsAg) with a viral load (HBV-DNA) >500 IU/mL or >2500 (units unclear, likely IU/mL.Viral load of hepatitis C virus (HCV-RNA) above the upper limit of normal for the testing facility. (Note: For participants who are positive for hepatitis B surface antigen [HBsAg], it is recommended to start antiviral therapy before the first administration of study drugs, using nucleoside analogs such as entecavir or tenofovir disoproxil fumarate.) 9. Active bacterial, fungal, or viral infection within 14 days prior to enrollment requiring intravenous antimicrobial, antifungal, or antiviral treatment. Participants receiving prophylactic anti-infective treatment without clinical signs of active infection at the time of screening may still be considered for inclusion; 10. Active tuberculosis or a history of tuberculosis; 11. History of severe cardiovascular disease within the past six months prior to enrollment, including but not limited to: stable angina classified as III-IV functional class; unstable angina or myocardial infarction; congestive heart failure classified as NYHA III-IV; clinically significant arrhythmias requiring medication (asymptomatic atrial fibrillation patients may be included if ventricular rate is well controlled); serious arterial/venous thromboembolic events such as hemorrhagic stroke, ischemic stroke, deep vein thrombosis, or pulmonary embolism; 12. Uncontrolled hypertension; 13. Interstitial lung disease or a history thereof, or non-infectious pneumonia requiring corticosteroid treatment; 14. Clinically significant hydronephrosis that, in the investigator’s judgme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Progression-free survival (PFS);Overall survival (OS);Safety profile?;Monitoring of immunological biomarkers related to treatment response; | — |
Countries
China
Contacts
Public ContactShujuan Liu
The First Affiliated Hospital of Airforce Medical University
Outcome results
None listed