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Neoadjuvant Iparomlimab and Tuvonralimab Plus Chemotherapy-eclipse for Locally Advanced Cervical Cancer (NICE-CC)

RecruitingPhase 2Ages 18 Years - 70 YearsFemaleFujian Cancer Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 1、History of other malignancies within 3 years * 2、Participate in other clinical trials at the same time * 3、Active autoimmune disease, which needs systemic therapy * 4、Uncontrolled infection, which needs systemic therapy * 5、History of allogeneic tissue/solid organ transplant * 6、Serious illness, such as severe mental disorders, cardiac disease, coagulation disorders, digestive system disease, etc * 7、Active HBV, HCV, or HIV infection * 8、Pregnant or lactating female patients * 9、Drug or alcohol abuse * 10、 Unable or unwilling to sign the informed consent
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What it tests

  • neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cycles
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Where

1 site
Fujian Cancer Hospital
Fuzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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