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.
1. Sign a written informed consent before any trial-related procedures. 2. Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma.
Other histopathological findings such as neuroendocrine carcinoma, sarcoma, gastric-type adenocarcinoma, and malignant melanoma components;
Previous receipt of anti-tumor treatment related to cervical cancer;
Evidence of distant metastasis, including lymph node metastasis in the groin, supraclavicular, and axillary regions;
Previous total hysterectomy or subtotal hysterectomy;
Single group
2 cycles of combined drug induction therapy: every 3 weeks for 2 cycles; After ,synchronous radiotherapy and chemotherapy combined immunotherapy
Combination productThe 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.
2-year PFS
2-year PFS rate evaluated by researchers based on RECIST v1.1 and biopsy pathology
ORR
ORR of drug-induced therapy evaluated by researchers based on RECIST v1.1 and biopsy pathology
DCR
DCR of drug-induced therapy evaluated by researchers based on RECIST v1.1 and biopsy pathology
OS
2-year OS
Click on the lead sponsor to view all of their trials.
Zhejiang Cancer Hospital
Lead sponsor
Cancer Hospital of The University of Chinese Academy of Sciences
Collaborator
Cancer Center of the First Affiliated Hospital of Soochow University
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Collaborator
People's Hospital of Quzhou
Collaborator
First Affiliated Hospital of Ningbo University
Collaborator
Wenzhou Central Hospital
Collaborator
Jinhua Municipal Central Hospital
Collaborator
First Hospital of Zhejiang University
Collaborator
First Affiliated Hospital of Zhejiang University
Collaborator
Henan Provincial People's Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
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