Actively Recruiting
A Phase III, Multicenter, Open-label, Randomized Controlled Study on Cadonilimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-05-13
378
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
A
Akesobio
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of Cadonilimab combined with chemotherapy followed by concurrent chemoradiotherapy compared to the standard concurrent chemoradiotherapy for treating locally advanced cervical cancer. This Phase III, multicenter, open-label randomized controlled study aims to improve treatment options for patients with this condition. The study includes three groups: one receiving standard concurrent chemoradiotherapy; another undergoing immune induction chemotherapy combined with reduced-dose radiotherapy and reduced-dose concurrent chemotherapy followed by immune maintenance therapy; and a third group receiving immune induction chemotherapy combined with reduced-dose radiotherapy followed by immune maintenance therapy after completing radiotherapy and chemotherapy. Treatments involve radiation therapy, chemotherapy drugs such as cisplatin and albumin paclitaxel, and the immunotherapy drug Cadonilimab administered in various dosing schedules. Participants will be monitored over time for progression-free survival using RECIST 1.1 criteria, with follow-up lasting up to approximately 55 months. Researchers will also assess objective response rates, overall survival, duration and time to response, and disease control rates. Safety and treatment effects will be evaluated through clinical assessments, imaging, and laboratory tests during regular study visits throughout the trial period.
CONDITIONS
Brief Title
A Clinical Study on the Treatment of LACC With Cadonilimab Combined With Chemotherapy Followed by CCRT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, aged 18 to 70 years inclusive
- Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- Stage IIB to IVA cervical cancer (FIGO 2018) with no previous antineoplastic therapy
- At least one measurable lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Adequate organ function
You will not qualify if you...
- Presence of distant metastatic disease including lymph node metastasis above the superior edge of L1 (FIGO 2018 stage IVB)
- Previous total hysterectomy removing corpus uteri and cervix
- Inability or refusal to undergo brachytherapy due to anatomical or other reasons
- Prior antineoplastic treatments such as surgery (except biopsy), radiotherapy, chemotherapy, immunotherapy, or targeted therapy
- Any condition judged by investigators as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive immune induction therapy combining Cadonilimab with chemotherapy drugs albumin paclitaxel and cisplatin.
Weekly visits for 6 weeks
Duration - About 5 weeks
Participants undergo reduced-dose radiotherapy combined with concurrent chemotherapy to treat cervical cancer.
Weekly chemotherapy visits plus radiotherapy sessions over 5 weeks
Duration - Up to 9 doses or approximately 6 months
Participants receive maintenance treatment with Cadonilimab after completing radiotherapy and chemotherapy to support ongoing cancer control.
Regular visits for immunotherapy dosing up to 6 months
Duration - Up to approximately 55 months
Participants are monitored for progression-free survival and overall health after completing treatment.
Periodic visits during follow-up phase
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
Research Team
T
Ting Liu, MD
G
Guiling Li, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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