Locally Advanced Cervical Carcinoma
Conditions
Brief summary
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.
Interventions
RADIATIONstandard EBRT+Brachytherapy
EBRT: 45-50.4Gy, Brachytherapy: 7Gy×4 or 6Gy ×5
DRUGConcurrent chemotherapy
Cisplatin 40mg/m2, qw×5
DRUGImmune induction therapy
Cadonilimab （Moderate dose）+ albumin paclitaxel 90mg/m2, qw×6+ cisplatin 25mg/m2, qw×6
RADIATIONReduced dose radiotherapy
EBRT: 45-50.4Gy; Brachytherapy: 6Gy×4
DRUGDose reduction concurrent chemotherapy
cisplatin 25mg/m2, qw×5
Cadonilimab （Moderate dose）×9 or half a year
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Akesobio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
To be enrolled, subjects had to meet all of the following criteria: 1. Female, aged 18-70 years (inclusive of cutoff values); 2. Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix; 3. Patients with stage IIB-IVA cervical cancer (FIGO stage 2018) who had not received any previous antineoplastic therapy; 4. At least one measurable lesion according to RECIST v1.1; 5. Eastern Cooperative Oncology Group (ECOG) performance-status score 0-1; 6. Have adequate organ function.
Exclusion criteria
Subjects were excluded from the study if they met any of the following criteria: 1. Distant metastatic disease (including inguinal lymph node metastasis and lymph node metastasis above the level of the superior edge of the L1 pyramid in the proximal cephalic region, according to FIGO 2018 stage IVB); 2. He had undergone total hysterectomy (removal of the corpus uteri and cervix); 3. Inability to undergo brachytherapy or refusal to undergo brachytherapy for reasons such as anatomical abnormalities; 4. Had received any previous antineoplastic therapy, including but not limited to surgery (except biopsy), radiotherapy, or systemic therapy (chemotherapy, immunotherapy, targeted therapy); 5. Had any condition that was deemed by other investigators to be ineligible for participation in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival(PFS) per RECIST 1.1 assessed by investigator(INV) | Up to approximately 55 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) per RECIST 1.1 | Up to approximately 55 months | Assessed by investigators |
| Overall Survival (OS) | Up to approximately 55 months | OS is defined as the time from randomization to death due to any cause. |
| Duration of Response (DOR) per RECIST 1.1 | Up to approximately 3 years | Assessed by investigators |
| Time to Response (TTR) per RECIST 1.1 | Up to approximately 3 years | Assessed by investigators |
| Disease Control Rate (DCR) per RECIST 1.1 | Up to approximately 3 years | Assessed by investigators |
Countries
China
Contacts
CONTACTTing Liu, MD
CONTACTGuiling Li, PHD
PRINCIPAL_INVESTIGATORGuiling Li, PHD
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed