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This is a prospective , single - arm clinical study , aiming to evaluate the efficacy and safety of Enlansibumab sequential concurrent chemoradiotherapy in locally advanced cervical cancer. Patients will first receive one cycle of Enlansibumab monotherapy (360 mg, 60 - min IV infusion on day 1, every 3 weeks). After one treatment cycle (3 weeks), they'll undergo imaging assessment. Then, they'll have Enlansibumab (360 mg, 60 - min IV infusion on day 1, every 3 weeks for two cycles) combined with concurrent chemoradiotherapy. Chemotherapy involves cisplatin (40 mg/m²) or carboplatin (AUC2) via IV infusion, weekly (±7 days), with five planned cycles. Investigators may add a sixth platinum - based chemotherapy cycle if needed. Radiotherapy comprises EBRT and BT and must be completed within eight weeks of treatment initiation. The total prescription dose of EBRT combined with BT should have an EQD2 of ≥8000 cGy, with adjustments based on tumor regression. After concurrent chemoradiotherapy, treatment ends. An imaging assessment occurs around seven days (±3 days) later. Then, the follow - up phase begins, including final, safety, and survival follow - ups, continuing until patients are lost to follow-up, the follow-up ends, or they die.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequential Enlonstobart Injection with concurrent chemoradiotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlonstobart Injection | Drug | Sequential Enlonstobart Injection with concurrent chemoradiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-year PFS rate | 1 year after treatment initiation |
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Inclusion criteria:
Female, aged 18-70 years (including boundary values);
Diagnosed histologically as cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma; 3.2018 FIGO stage IIB-IVA; Assess lymph node involvement based on one of the following criteria:
According to the evaluation criteria for solid tumor efficacy version 1.1 (RECIST v1.1), having at least one measurable lesion; 5.ECOG PS 0-1; 6. According to the researcher's judgment, those with an expected survival period of ≥ 3 months; 7. The subjects can provide tumor tissue sections to determine whether formalin fixed paraffin embedded tumor histopathological samples or fresh tumor histopathological samples can be used for PD-L1 expression and other immune indicators detection; 8. Have sufficient organ function and meet the following laboratory examination standards:
11. The subjects voluntarily participated in this study, had good compliance with the planned treatment and follow-up, understood the research process of this study, and voluntarily signed an informed consent form.
Exclusion criteria:
16. Known recipients of organ transplantation or allogeneic hematopoietic stem cell transplantation; 17. Have a history of severe allergic reactions and uncontrolled allergic asthma to all components of monoclonal antibody preparations; 18. There are contraindications or severe allergic reactions to any component of cisplatin; 19. Individuals who have participated in other clinical trials and used the investigational drug within 28 days prior to enrollment; 20. Participants who may have poor compliance with the research procedures and requirements, as determined by the researchers, such as those with a clear history of neurological or psychiatric disorders (including epilepsy or dementia), current mental disorders, and substance abuse; 21. Individuals with a clear history of neurological or mental disorders or drug abuse who are unable to quit or have a history of drug use; 22. There are situations where other researchers have determined that it is not suitable to participate in this experiment.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongling Zou | Contact | 13657690699 | 13570049@qq.com |
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