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

Summary

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.

Eligibility

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

Conditions2

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