Clinical Trial

a Single Arm, Phase II Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Combination Therapy of Iparomlimab and Tuvonralima b and Chemotherapy ± Bevacizumab Induction Therapy Followed by Concurrent Chemoradiotherapy in Patients With Advanced Cervical Cancer .

Not Yet Recruiting Phase 2
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Summary
This study is a single arm, phase II multicenter clinical trial to evaluate the efficacy and safety of the combination therapy of Iparomlimab and Tuvonralimab(QL1706) and chemotherapy ± bevacizumab induction therapy followed by concurrent chemoradiotherapy in patients with locally advanced cervical cancer at high risk of IVA stage and/or giant cervical tumors and/or giant metastatic lymph nodes and/or multiple metastatic lymph nodes. The enrolled patients first receive 2 cycles of combined drug induction therapy: paclitaxel+cisplatin/carboplatin ± bevacizumab+QL1706, every 3 weeks for 2 cycles; After induction therapy, synchronous radiotherapy and chemotherapy combined with immunotherapy: extracorporeal irradiation+post loading radiotherapy+synchronous chemotherapy+immunotherapy. During radiotherapy, single agent cisplatin/carboplatin treatment for 5 courses per week+QL1706 treatment every 3 weeks for 3 courses; After the end of radiotherapy and chemotherapy, immune maintenance therapy will be administered for six months: treatment with QL1706 every 3 weeks for 9 courses, followed by a follow-up period until the end of radiotherapy for 2 years or death.
Trial Details
NCT Number NCT07035808
Lead Sponsor Zhejiang Cancer Hospital
Collaborators: Cancer Center of the First Affiliated Hospital of Soochow University, The First Affiliated Hospital of Nanchang University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, People's Hospital of Quzhou, First Affiliated Hospital of Ningbo University, Wenzhou Central Hospital, Jinhua Municipal Central Hospital, First Affiliated Hospital of Zhejiang University, Henan Provincial People's Hospital, Xiangya Hospital of Central South University
Conditions Cervical Cancer Stage IVA, Cervical Cancer Metastatic
Enrollment 46 participants
Start Date 2025-07-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-06-25