Enlonstobart with chemotherapy and radiotherapy for locally advanced cervical cancer
Official title: An Exploratory Study on the Efficacy and Safety of Enlonstobart Combined With Concurrent Radiotherapy and Chemotherapy Following Induction Therapy With Enlonstobart Plus Chemotherapy in Patients With Locally Advanced Cervical Cancer.
Run by Tianjin Medical University Cancer Institute and Hospital · NCT07776821 · Data updated 2026-11-12
This study tests whether adding Enlonstobart to standard chemotherapy and chemoradiotherapy helps patients with locally advanced cervical cancer by increasing response rates and monitoring safety.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 31 (estimated) |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | prednisone, chemotherapy, radiation |
| Locations | 2 sites (Tianjin and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | November 1, 2026 |
| Study ends | November 1, 2026 |
| Registry record updated | August 25, 2026 |
| Trial ID | NCT07776821 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-75 with newly diagnosed locally advanced cervical cancer (FIGO III–IV A), specific histologies, good performance status (ECOG 0-1), and adequate organ function.
✕Probably not a fit
Patients with contraindications to Enlonstobart, significant organ dysfunction, or intolerance to chemotherapy/radiotherapy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 4 interventional trial evaluating the use of Enlonstobart in combination with induction chemotherapy followed by concurrent radiotherapy and chemotherapy for locally advanced cervical cancer. Participants receive induction therapy with Enlonstobart plus chemotherapy, then proceed to concurrent chemoradiotherapy with Enlonstobart continuing alongside treatment and radiotherapy. The trial includes regular imaging and safety assessments to measure objective response rate, disease control rate, and tolerability, as well as documentation of adverse events. Eligibility focuses on adults with specific histologies and FIGO stage III–IV A disease, good performance status, and adequate organ function. The study is conducted at Tianjin Medical University Cancer Institute and Hospital and affiliated centers in Tianjin, China.
Why it matters
Potential benefit: If successful, patients may experience higher tumor response and better disease control with the Enlonstobart-containing regimen.
How similar studies have gone: Prior approaches combining novel agents with chemoradiotherapy have shown potential benefits, but this exact Enlonstobart strategy is exploratory in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Tianjin Cancer Hospital Airport Branch
Tianjin, China Recruiting -
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China Recruiting
Study contacts
- Study coordinator: Liming Xu Liming Xu
- Email: xuliming@tjmuch.com
- Phone: 18502255218
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.