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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
486
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
Fujian Cancer Hospital
Fuzhou, Fujian, China
Progression-Free Survival(PFS)
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
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 60 months
Objective Response Rate (ORR)
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 60 months
Disease Control Rate (DCR)
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 3 years
Clinical Complete Response Rate, CCR
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 6 months
Duration of Response (DOR)
Assessed by investigators
Time frame: Up to approximately 3 years
Time to Response (TTR)
Assessed by investigators
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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 3 years
Time to Progression (TTP)
Assessed by investigators
Time frame: Up to approximately 3 years
Quality of Life Assessed by Patient-Reported Outcome Questionnaires (QoL)
Quality of life will be assessed using EORTC QLQ-C30, EORTC QLQ-CX24, and EQ-5D questionnaires.
Time frame: Up to approximately 3 years
Incidence of brachytherapy dose reduction
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 6 months
Percentage of Participants With Adverse Events (AEs)
Number of participants with adverse events (AEs) according to CTCAE 5.0
Time frame: Up to approximately 3 years