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NCT07876154
Iparomlimab/Tuvonralimab Combined With Nab-paclitaxel and Cisplatin as Neoadjuvant Therapy for Locally Advanced Cervical Cancer
Conditions: Locally Advanced Cervical Cancer
Sex: Female
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 34
Sponsor: Xijing Hospital
Location: The First Affiliated Hospital of Airforce Medical University Xi'an Shaanxi
Summary
The goal of this clinical trial is to learn if Iparomlimab/Tuvonralimab combined with nab-paclitaxel and cisplatin as neoadjuvant treatment can treat locally advanced cervical cancer in adult female patients. It will also learn about the safety of this combination regimen. The main questions it aims to answer are:
What is the pathological complete response (pCR) rate after neoadjuvant combination therapy? What are the objective response rate, progression-free survival, overall survival, biomarker changes and tumor immune microenvironment changes in participants receiving this regimen?
There is no comparison group in this single-arm study.
Participants will:
* Receive neoadjuvant treatment with Iparomlimab/Tuvonralimab, albumin-bound paclitaxel and cisplatin
* Undergo radical surgery after completion of neoadjuvant therapy
* Receive scheduled imaging, blood and tissue biomarker tests
* Be followed up regularly for survival and safety assessment.
Eligibility 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:
1. Hematology (no blood transfusion, hematopoietic growth factors, or other medications affecting blood counts within 14 days): absolute neutrophil count (ANC) \>= 1.5×10⁹/L; platelet count (PLT) \>= 80×10⁹/L; hemoglobin (HGB) \>= 90 g/L;
2. Biochemistry: serum creatinine \= 60 mL/min calculated using the Cockcroft-Gault formula if \>1.5 × ULN; total bilirubin (TBIL) \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 judgment, cannot be relieved through nephrostomy or ureteral stent placement; 15. Receipt of or planned administration of live or attenuated vaccines within 28 days before enrollment or during the study period; 16. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 17. History of severe allergic reactions to any component of monoclonal antibody formulations, or uncontrolled allergic asthma; 18. Contraindication to or history of severe allergic reaction to nab-paclitaxel, cisplatin, carboplatin, or any ingredient in the immunotherapy agents; 19. Participation in another clinical trial with administration of investigational drug within 28 days prior to enrollment; 20. Clear history of neurological or psychiatric disorders, substance abuse, or drug addiction that cannot be ceased or for which there is documented illicit drug use; 21. Any other condition deemed unsuitable for participation in this study by the investigator.
Source: ClinicalTrials.gov (NCT07876154). StuddyBuddy aggregates publicly available trial information.