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.
A total of 43 patients with FIGO 2018 stages IB3, IIA2, IIB, or IIIC1r will receive a combination treatment consisting of iparomlimab and tuvonralimab (5 mg/kg administered intravenously), cisplatin (75-80 mg/m², intravenously), and nab-paclitaxel (260 mg/m², intravenously) for one cycle. Following this, patients will receive two additional cycles of iparomlimab and tuvonralimab at the same dosage of 5 mg/kg, administered at three-week intervals. After completing three cycles of neoadjuvant treatment, patients who show a complete response (CR) or partial response (PR) will undergo radical surgery. The decision regarding subsequent adjuvant therapy will be guided by the NCCN guidelines. In contrast, patients with stable or progressive disease will proceed to concurrent chemoradiotherapy (CCRT).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
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)
Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGPathological complete response (pCR)
Pathological complete response（pCR） is defined as the absence of viable tumor cells by surgery
Time frame: From enrollment to the end of surgery at 3 months
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.
Time frame: From enrollment to the end of surgery at 3 months
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.
Time frame: Through the study completion, an average of 2 year
Primary pathological response (MPR)
MPR is defined as having no more than 10% viable tumor by surgery.
Time frame: From enrollment to the end of surgery at 3 months
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.
Time frame: Through the study completion, an average of 2 year
Adverse events
Incidence of Treatment-Emergent Adverse Events, Including adverse events and complications. Incidence of adverse events using CTCAE 5.0; grade 3 treatment-related adverse events and higher-grade will be reported
Time frame: During the treatment（12months）
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