Actively Recruiting
Iparomlimab/Tuvonralimab Injection Plus CCRT in LACC
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-12-01
30
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a clinical study to evaluate the safety and efficacy of Iparomlimab/Tuvonralimab Injection (QL1706, a Bifunctional Mabpair Product of Anti-PD-1 and Anti-CTLA-4 Antibodies) in Combination With Concurrent Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer.
CONDITIONS
Official Title
Iparomlimab/Tuvonralimab Injection Plus CCRT in LACC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- Signed informed consent
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Histologically confirmed HPV-related cervical squamous, adenocarcinoma, or adenosquamous carcinoma
- FIGO 2018 stage T3a-4a (III-IVA), N1 (lymph node metastasis), M0
- At least one evaluable tumor per RECIST 1.1 criteria
- Adequate organ function including hematology, renal, hepatic, coagulation, and cardiac parameters
- Negative pregnancy test within 3 days before first study drug dose for women of childbearing potential
- Use of acceptable contraception during study and for 120 days after last dose
- Willingness to follow study procedures
You will not qualify if you...
- Cervical cancer of other histology (e.g., neuroendocrine carcinoma, sarcoma)
- Evidence of distant metastasis
- Prior total hysterectomy (subtotal or cervical-sparing surgery allowed)
- Unable or unwilling to receive brachytherapy
- Prior treatment with immune checkpoint inhibitors or other tumor immunotherapy
- Use of systemic corticosteroids (>10 mg/day prednisone or equivalent) or immunosuppressive therapy within 2 weeks (exceptions allowed)
- Use of immunomodulatory drugs within 2 weeks (e.g., thymosin, interferons, IL-2)
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Center/Cancer Hospital
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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