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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFujian Cancer Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

43 Participants
are divided into 1 treatment group

Sponsors and collaborators

Fujian Cancer Hospital

Lead sponsor

Jiangsu Cancer Institute & Hospital

Collaborator

Fuzhou University Affiliated Provincial Hospital

Collaborator

First Affiliated Hospital of Fujian Medical University

Collaborator