Neoadjuvant Therapy of Iparomlimab and Tuvonralimab Combined With Chemotherapy-eclipse for Locally Advanced Cervical Cancer：A Single-arm, Open-label, Phase II Trial
Locally advanced cervical cancer (LACC) remains a significant global health concern with limited treatment options. Recent advancements suggest that using neoadjuvant anti-PD-1 inhibitors in combination with chemotherapy, followed by radical surgery, may be an effective treatment strategy for patients with PD-L1-positive LACC. This study aims to evaluate the efficacy and safety of preoperative treatment with iparomlimab and tuvonralimab-a bifunctional PD-1/CTLA-4 dual blocker-combined with chemotherapy for LACC.
• 1、Written informed consent
• 2、18-70 years old
• 3、Adequate organ function and ECOG of 0 \
⁃ 1
• 4、Without systemic therapy at the time of enrollment
• 5、FIGO 2018 stage IB3, IIA2, or IIIC1r
• 6、Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
• 7、Measurable lesions could be defined by RECIST v1.1
• 8、Willing to get blood/ tumor tissue tested
• 9、Patients who observed the rules about the scheduled visit, study schedule, and medical examination
• 10、The function of major organs is normal, and the following criteria are met:
• 10.1 Blood routine examination must meet: (no blood transfusion within 14 days)
⁃ Hb≥90g/L:
⁃ ANC≥1.5x10\^9/L; PLT≥100x10\^9/L;
• 10.2 The biochemical examination must meet the following standards BIL \< 1.5 × ULN; ALT and AST \< 2.5xULN; ALB≥ 28 g/L
• 11、Patients who are willing and able to comply with visiting arrangements, treatment plans, laboratory tests, and other research procedures.