This is a single-arm, single-center, exploratory study, the purpose of this study is to evaluate the efficacy and safety of envafolimab combined with Chemoradiotherapy in participants with locally advanced cervical cancer.
The subject voluntarily joins this study and is able to sign the informed consent form with good compliance;
Female aged 18-75 years (at the time of signing the informed consent);
ECOG score of 0-1 within 7 days prior to first study intervention dose;
Expectation of life ≥ 12 weeks;
Patients who had or currently had other malignant tumors within 3 years prior to the start of study treatment;
Inability to perform (complete) brachytherapy due to anatomy, tumor shape, contraindications, etc.;
Grade ≥ 1 unresolved toxicity due to any prior therapy (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 5.0 [CTCAE 5.0]);
Unsatisfactory blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
Single group
Envafolimab
DrugSC
Cisplatin
DrugIV infusion
External Beam Radiotherapy (EBRT)
Radiation45-50.4Gy
Brachytherapy (BT)
RadiationPerformed according to clinically required dose
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Month 24 as Assessed by the Investigator
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 24 using the entire PFS data up to the cut-off date.
Objective Response Rate(ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.
Duration of response (DoR)
The DoR is defined as the time from first response to disease progression or death in the absence of disease progression. First response was defined as first CR or PR was achieved. DoR will be summarized for responding patients and DoR rates (%) at 12, 24, and 36 months will be provided.
Progression-Free Survival (PFS) at Month 12/36
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 12/36 using the entire PFS data up to the cut-off date.
Overall Survival (OS) at Month 12/24/36
OS is the time from randomization to death due to any cause. OS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the OS rate at Month 12/24/36 using the entire OS data up to the cut-off date.
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