Neoadjuvant Iparomlimab and Tuvonralimab Combined with Paclitaxel and Platinum Chemotherapy for Treating Locally Advanced Cervical Cancer in Women

What this Trial Is About

Researchers are studying the use of a new combination treatment involving iparomlimab and tuvonralimab QL1706, a dual PD-1 and CTLA-4 bispecific antibody, paired with paclitaxel and either cisplatin or carboplatin chemotherapy for women with locally advanced cervical cancer. The study focuses on patients with newly diagnosed cervical cancer at specific stages FIGO IB3 or IIA2 without significant lymph node involvement, assessing whether this neoadjuvant therapy is effective and safe before surgery. Participants will receive up to four cycles of the combined QL1706 and chemotherapy regimen every three weeks before surgery. After two cycles, their tumor response will be evaluated if tumor shrinkage is observed, treatment continues for two more cycles followed by imaging to guide surgical decisions. Depending on their response, some patients may undergo less extensive surgery, while others may have standard radical hysterectomy. Those with optimal pathological response after surgery may receive up to eight additional cycles of QL1706 as maintenance therapy. If surgery is not tolerated or contraindicated, radical radiotherapy will be provided. Throughout the study, participants will have clinical assessments, imaging, and pathological evaluations to measure tumor response and safety. Researchers will monitor treatment-related adverse events and quality of life using patient questionnaires over up to three years. The main outcome is the rate of complete pathological response in surgical tissue after neoadjuvant treatment. Total participation time is expected to last approximately nine to twelve months, covering treatment, surgery, and possible maintenance therapy.

Iparomlimab and Tuvonralimab Plus Paclitaxel and Platinum as Neoadjuvant Therapy for Locally Advanced Cervical Cancer