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 .

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorZhejiang Cancer Hospital

About this trial

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.

Eligibility criteria

Qualifiers

1. Sign a written informed consent before any trial-related procedures. 2. Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • 2 cycles of combined drug induction therapy: every 3 weeks for 2 cycles; After ,synchronous radiotherapy and chemotherapy combined immunotherapy

Treatment groups

46 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

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