The objective of this clinical trial is to investigate the efficacy and safety of Enlonstobart combined with concurrent chemoradiotherapy following induction chemotherapy for locally advanced cervical cancer. The primary questions it aims to address are:
Can the Enlonstobart combination regimen improve the objective response rate and disease control rate in patients with locally advanced cervical cancer? What is the safety and tolerability profile of this combination regimen, and will any unexpected serious adverse events occur?
Participants will:
Receive induction therapy with Enlonstobart in combination with chemotherapy agents (e.g., paclitaxel plus platinum); Receive Enlonstobart in combination with concurrent chemoradiotherapy (external beam radiation therapy plus brachytherapy, with concurrent chemotherapy); Undergo regular tumor imaging evaluations (CT/MRI) and hematological safety assessments; Cooperate in completing efficacy assessments, adverse event documentation, and long-term follow-up.
Ages 18-75;
Cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma confirmed by histology or cytopathology;
Patients with locally advanced cervical cancer who have not previously received any treatment and are classified as FIGO stage III-IV A as of 2018;
ECOG performance status 0-1;
A history of active malignant tumors within 3 years prior to the first dose, excluding cervical cancer, which is the subject of this trial, and any locally curable tumors that have already undergone curative treatment (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, or cured carcinoma in situ, such as ductal carcinoma in situ of the breast);
Patients with active tuberculosis or a history of tuberculosis;
Patients with a history of interstitial lung disease or non-infectious pneumonia requiring glucocorticoid therapy;
Patients with hypertension that is not adequately controlled with antihypertensive medication (defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy;
Tianjin Medical University Cancer Institute and Hospital
Lead sponsor
Tianjin Cancer Hospital Airport Hospital
Collaborator