A Phase III, Multicenter, Open-label, Randomized Controlled Clinical Study on the Treatment of Locally Advanced Cervical Cancer With Cadonilimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy
Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study mainly evaluated the efficacy and safety of Cadonilimab combined with chemotherapy followed by concurrent chemoradiotherapy versus standard concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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⁃ To be enrolled, subjects had to meet all of the following criteria:
• Female, aged 18-70 years (inclusive of cutoff values);
• Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix;
• Patients with stage IIB-IVA cervical cancer (FIGO stage 2018) who had not received any previous antineoplastic therapy;
• At least one measurable lesion according to RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance-status score 0-1;
• Have adequate organ function.
Locations
Other Locations
China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Ting Liu, MD
clinicaltrials@akesobio.com
+86 (0760) 8987 3999
Backup
Guiling Li, PHD
(+86)027-85726685
Time Frame
Start Date:2026-04-24
Estimated Completion Date:2032-07-20
Participants
Target number of participants:378
Treatments
Active_comparator: Standard concurrent chemoradiotherapy（CCRT）
Undergo immune induction chemotherapy combined with reduced-dose radiotherapy and reduced-dose concurrent chemotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy.
Undergo immune induction chemotherapy combined with reduced-dose radiotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy.