NCT07035808

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 .

Efficacy and Safety of Iparomlimab and Tuvonralimab(QL1706) Combined With Chemotherapy ± Bevacizumab Induction Therapy Followed by Concurrent Chemoradiotherapy for High-risk Locally Advanced Cervical Cancer：a Single Arm, Phase II Multicenter Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer Stage IVA
• Cervical Cancer Metastatic

Interventions

Type	Name	Description
COMBINATION_PRODUCT	2 cycles of combined drug induction therapy: every 3 weeks for 2 cycles; After ,synchronous radiotherapy and chemotherapy combined immunotherapy	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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2025-06-25
• Last updated: 2025-06-25