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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard concurrent chemoradiotherapy(CCRT) | Active Comparator | Accept standard concurrent chemoradiotherapy |
|
| Neoadjuvant Therapy Group | Experimental | Participants in the experimental arm will receive 2 cycles of QL1706 + paclitaxel (albumin-bound) + Cisplatin/Carboplatin. Following neoadjuvant therapy, patients will undergo EBRT + QL1706. After EBRT completion, patients with clinical complete response (CCR) will receive brachytherapy at a dose of 600 cGy × 3 fractions; patients without CCR will receive brachytherapy at a dose of 600 cGy × 5 fractions. Subsequent sequential QL1706 will be administered for up to 2 years, until disease progression, or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard EBRT+Brachytherapy | Radiation | EBRT: 45-50.4Gy, Brachytherapy: 6Gy ×5 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Xu | Contact | 13950419396 | xuqin@fjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
Individual participant data will not be shared because of privacy protection and ethical restrictions. Deidentified aggregate results may be shared in publications.
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This is a randomized, controlled, multicenter, phase III clinical study. Enrolled participants will be randomly assigned in a 1:1 ratio to the neoadjuvant therapy group and the standard concurrent chemoradiotherapy group.
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| Cisplatin | Drug | Cisplatin 40mg/m2, qw×5 |
|
| Neoadjuvant chemoimmunotherapy | Drug | 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 |
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| Radiotherapy combined with immunotherapy | Radiation | 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. |
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| Immunomaintenance therapy | Drug | 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. |
|
| 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 | 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. | Up to approximately 6 months |
| Duration of Response (DOR) | Assessed by investigators | Up to approximately 3 years |
| Time to Response (TTR) | Assessed by investigators | Up to approximately 3 years |
| Time to Progression (TTP) | Assessed by investigators | 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. | 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). | Up to approximately 6 months |
| Percentage of Participants With Adverse Events (AEs) | Number of participants with adverse events (AEs) according to CTCAE 5.0 | Up to approximately 3 years |
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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