Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
NCT Number: NCT07613567
This study aims to compare the efficacy and safety of "neoadjuvant immunotherapy combined with chemotherapy followed by immunotherapy combined with radiotherapy during the radiotherapy period" versus "standard concurrent chemoradiotherapy" in locally advanced cervical cancer.
Trial opening soon.
Get Notified18 year–75 year
Female
Interventional
Phase 3
Fuzhou, Fujian, 350014, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
EBRT: 45-50.4Gy, Brachytherapy: 6Gy ×5
Cisplatin 40mg/m2, qw×5
Neoadjuvant phase: total of 2 cycles. Iparomlimab/Tuvonralimab 5mg/kg,D1,Q3W + albumin paclitaxel 90mg/m2, D1、8、15,Q3W+ Cisplatin 25mg/m2 or Carboplatin AUC = 1.5 , D1、8、15,Q3W
Following neoadjuvant therapy, patients will receive EBRT + QL1706. After EBRT completion, brachytherapy dose is 600 cGy × 3 fractions for patients with clinical complete response (CCR), and 600 cGy × 5 fractions for non-CCR patients.
Iparomlimab/Tuvonralimab (QL1706) 5 mg/kg,D1,Q3W. Will be administered for up to 2 years, until disease progression, or until unacceptable toxicity, whichever occurs first.
Time frame: Up to approximately 60 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 60 months
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 60 months
ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed investigator per RECIST 1.1
Time frame: Up to approximately 3 years
DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by investigator per RECIST 1.1
Time frame: Up to approximately 6 months
Defined as the absence of measurable tumor lesions on clinical examination and imaging assessment, which may be adjunctively confirmed by necessary pathological examinations (such as cervical biopsy). CCR is primarily used to guide brachytherapy dose stratification and is not used as a criterion for PFS event determination.
Time frame: Up to approximately 3 years
Assessed by investigators
Time frame: Up to approximately 3 years
Assessed by investigators
Time frame: Up to approximately 3 years
Assessed by investigators
Time frame: Up to approximately 3 years
Quality of life will be assessed using EORTC QLQ-C30, EORTC QLQ-CX24, and EQ-5D questionnaires.
Time frame: Up to approximately 6 months
Defined as the proportion of participants who, after completion of external beam radiotherapy (EBRT) and originally planned to receive the standard brachytherapy dose regimen (5 fractions), achieved the predefined clinical complete response (CCR) criteria and, upon investigator assessment, actually received a reduced number of brachytherapy fractions (3 fractions).
Time frame: Up to approximately 3 years
Number of participants with adverse events (AEs) according to CTCAE 5.0
Contact information is provided by the study sponsor or research team.
Fujian Cancer Hospital
Other Gov
A Randomized, Multicenter, Phase III Study of Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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