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| Name | Class |
|---|---|
| Akesobio | INDUSTRY |
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This study mainly evaluated the efficacy and safety of Cadonilimab combined with chemotherapy followed by concurrent chemoradiotherapy versus standard concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard concurrent chemoradiotherapy(CCRT) | Active Comparator | Accept standard concurrent chemoradiotherapy |
|
| Cadonilimab+Induction chemotherapy+reduced-dose CCRT+Cadonilimab | Experimental | Undergo immune induction chemotherapy combined with reduced-dose radiotherapy and reduced-dose concurrent chemotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy. |
|
| Cadonilimab+Induction chemotherapy+reduced-dose radiotherapy+Cadonilimab | Experimental | Undergo immune induction chemotherapy combined with reduced-dose radiotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard EBRT+Brachytherapy | Radiation | EBRT: 45-50.4Gy, Brachytherapy: 7Gy×4 or 6Gy ×5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival(PFS) per RECIST 1.1 assessed by investigator(INV) | 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 55 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) per RECIST 1.1 | Assessed by investigators | Up to approximately 55 months |
| Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. |
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Inclusion Criteria:
To be enrolled, subjects had to meet all of the following criteria:
Exclusion Criteria:
Subjects were excluded from the study if they met any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Liu, MD | Contact | +86 (0760) 8987 3999 | clinicaltrials@akesobio.com | |
| Guiling Li, PHD | Contact | (+86)027-85726685 |
| Name | Affiliation | Role |
|---|---|---|
| Guiling Li, PHD | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
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| Concurrent chemotherapy | Drug | Cisplatin 40mg/m2, qw×5 |
|
| Immune induction therapy | Drug | Cadonilimab (Moderate dose)+ albumin paclitaxel 90mg/m2, qw×6+ cisplatin 25mg/m2, qw×6 |
|
| Reduced dose radiotherapy | Radiation | EBRT: 45-50.4Gy; Brachytherapy: 6Gy×4 |
|
| Dose reduction concurrent chemotherapy | Drug | cisplatin 25mg/m2, qw×5 |
|
| Immunomaintenance therapy | Drug | Cadonilimab (Moderate dose)×9 or half a year |
|
| Up to approximately 55 months |
| Duration of Response (DOR) per RECIST 1.1 | Assessed by investigators | Up to approximately 3 years |
| Time to Response (TTR) per RECIST 1.1 | Assessed by investigators | Up to approximately 3 years |
| Disease Control Rate (DCR) per RECIST 1.1 | Assessed by investigators | Up to approximately 3 years |