neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cycles
neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cycles: Neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab, cisplatin, and nab-paclitaxel for 1 cycle, then Iparomlimab and tuvonralimab continued for 2 cycles at 3-week intervals. Details:
Iparomlimab and tuvonralimab 5 mg/kg, IV infusion, Q3W for 3 cycles Cisplatin：75-80 mg/m2, IV infusion, (cycle 1) Nab-paclitaxel 260 mg/m2，30min，IV infusion,(cycle 1)
Study 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
Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Pathological complete response (pCR) — From enrollment to the end of surgery at 3 months Pathological complete response（pCR） is defined as the absence of viable tumor cells by surgery
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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