Actively Recruiting
Led by Fujian Cancer Hospital · Updated on 2025-09-11
43
Participants Needed
1
Research Sites
156 weeks
Total Duration
F
Fujian Cancer Hospital
Lead Sponsor
J
Jiangsu Cancer Institute & Hospital
Collaborating Sponsor
Locally advanced cervical cancer (LACC) is a serious health issue with limited treatment options. Researchers are evaluating the use of neoadjuvant therapy combining two immune checkpoint blockers, iparomlimab and tuvonralimab, with chemotherapy before surgery to treat patients with PD-L1-positive LACC. This phase II trial aims to assess the effectiveness and safety of this preoperative treatment approach. Participants will receive one cycle of combined treatment with iparomlimab, tuvonralimab, cisplatin, and nab-paclitaxel, all given intravenously. This is followed by two additional cycles of iparomlimab and tuvonralimab alone every three weeks. After completing three cycles, patients who respond well will undergo radical surgery. Depending on surgery results and guidelines, further treatment may be given, while those with stable or worsening disease will receive chemoradiotherapy. Throughout the study, participants will have regular evaluations including tumor measurements and lab tests. Researchers will measure responses up to surgery at three months, focusing on complete pathological response. Additional outcomes include survival rates up to two years and monitoring of side effects during the 12-month treatment period. The total study duration involves treatment, surgery, and follow-up assessments to understand treatment impact and safety.
CONDITIONS
Neoadjuvant Iparomlimab and Tuvonralimab Plus Chemotherapy-eclipse for Locally Advanced Cervical Cancer (NICE-CC)
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks
Participants receive three cycles of neoadjuvant chemo-immunotherapy. The first cycle includes iparomlimab, tuvonralimab, cisplatin, and nab-paclitaxel administered intravenously on day 1. The following two cycles consist of iparomlimab and tuvonralimab only, given at three-week intervals.
3 visits (in-person), one per treatment cycle
Duration - 1 day
Participants who achieve a complete or partial response after neoadjuvant treatment will undergo radical surgery.
1 visit (in-person)
Duration - Up to 2 years
Participants will be monitored post-surgery according to guidelines, which may include adjuvant therapy or chemoradiotherapy depending on disease status.
Follow-up visits as per clinical guidelines
Total: 1 location
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
Y
Yang Sun, PHD
J
Jie Lin, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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