Uterine Cervical Neoplasms
Conditions
Keywords
locally advanced carcinoma of the cervix
Brief summary
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.
Interventions
DRUGEnlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother
Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Tianjin Cancer Hospital Airport Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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; * Left ventricular ejection fraction (LVEF) ≥ 50%; * Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, hemoglobin ≥ 90 g/dL, platelets (PLT) ≥ 100 × 10⁹/L; * Liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 2.5 times the upper limit of normal (ULN); if liver metastases are present, ≤ 5×ULN; total bilirubin ≤ 1.5×ULN (this limit may be relaxed to 3×ULN for subjects with Gilbert's syndrome); * Renal function: Serum creatinine (Cr) ≤ 1.5×ULN; if \> 1.5×ULN, creatinine clearance must be ≥ 60 mL/min (calculated using the Cockcroft-Gault formula); * Coagulation: Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5×ULN; * According to the RECIST 1.1 criteria, the patient must have at least one evaluable lesion; * Patients of childbearing potential must have a negative pregnancy test result and voluntarily use effective and reliable contraception during the study; * Voluntarily participate in the study and sign an informed consent form.
Exclusion criteria
* 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; * Those who have experienced a serious cardiovascular event within 6 months prior to randomization, including but not limited to: stable angina classified as NYHA Class III-IV; unstable angina or myocardial infarction; NYHA Class III-IV congestive heart failure; severe arrhythmias requiring medication (asymptomatic atrial fibrillation is permitted if the ventricular rate can be controlled); Severe arterial or venous thromboembolic events (e.g., intracerebral hemorrhage, cerebral infarction, deep vein thrombosis, and pulmonary embolism); * Patients with active autoimmune diseases, or a history of autoimmune diseases within the 2 years prior to randomization, who still require systemic treatment. However, subjects with the following conditions may be considered for further screening: well-controlled type 1 diabetes; hypothyroidism requiring only hormone replacement therapy and well-controlled; skin diseases not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia); or subjects whose condition is not expected to recur in the absence of external triggers. * Individuals with a known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS); * Subjects with uncontrolled pleural, pericardial, or abdominal/pelvic effusions requiring repeated drainage; * Subjects who have received immunosuppressive drugs or systemic corticosteroids for the purpose of immunosuppression (prednisone \>10 mg/day or other equivalent medications) within 2 weeks prior to receiving the study drug; * Subjects who have undergone major surgery (craniotomy, thoracotomy, or laparotomy) within 28 days prior to the first administration of the study drug, or who still have unhealed wounds, ulcers, or fractures at the time of screening; * Subjects with a history of allogeneic hematopoietic stem cell transplantation or organ transplantation; * Subjects with other conditions deemed by the investigator to be incompatible with participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | From first dose of study drug to documented disease progression, death, or study discontinuation for any reason, whichever occurs first, assessed up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival(PFS) | From first dose of study drug to documented disease progression or death from any cause, whichever occurs first, assessed up to 3 years. |
| Disease Control Rate(DCR) | From first dose of study drug to documented disease progression, death, or study discontinuation for any reason, whichever occurs first, assessed up to 3 years. |
| Overall Survival(OS) | From first dose of study drug to death from any cause, or end of study/data cutoff, assessed up to 3 years. |
| 3-year progression-free survival rate | From first dose of study drug to documented disease progression or death from any cause, whichever occurs first; the 3-year PFS rate will be assessed at 36 months. |
| 3-year overall survival rate | From first dose of study drug to death from any cause; the 3-year OS rate will be assessed at 36 months. |
Countries
China
Contacts
CONTACTLiming Xu Liming Xu
CONTACTYaomei Ma
Outcome results
None listed