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
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
Single group
neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cycles
DrugNeoadjuvant 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)
Pathological complete response (pCR)
Pathological complete response（pCR） is defined as the absence of viable tumor cells by surgery
Objective response rate (ORR)
ORR is defined as the proportion of patients who achieve either a complete or partial response, as assessed by two experienced medical oncologists according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Event-free survival (EFS)
EFS is defined as the time from initial treatment to the date of disease progression that prevents definitive surgery, local or distant recurrence, occurrence of a second primary cancer, or death from any cause, whichever occurs first.
Primary pathological response (MPR)
MPR is defined as having no more than 10% viable tumor by surgery.
Disease-free survival (DFS)
DFS is the interval from the initial treatment to the first occurrence of locoregional failure, distant metastasis, or death from any cause.
Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry
Using flow cytometry to analyze the peripheral blood mononuclear cells to predict the efficacy of neoadjuvant chemo-immunotherapy. Results will be summarized by dose level
Tumor micrioenviroment assessment
using tumor tissue (multiple immunofluorescence) to assess immune cells before and after 3 cycles of neoadjuvant chemo-immunotherapy
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Fujian Cancer Hospital
Lead sponsor
Jiangsu Cancer Institute & Hospital
Collaborator
Fuzhou University Affiliated Provincial Hospital
Collaborator
First Affiliated Hospital of Fujian Medical University
Collaborator
