Can an immunotherapy combo boost cervical cancer treatment?

NCT ID NCT07776821

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This trial is testing whether adding the immunotherapy drug enlonstobart to standard chemotherapy and radiation can improve outcomes for people with locally advanced cervical cancer. Participants first receive enlonstobart with chemotherapy, then continue enlonstobart alongside chemoradiation. The study aims to see if this approach increases tumor shrinkage and helps control the disease longer, while also checking safety and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Enlonstobart (an immunotherapy drug) combined with chemotherapy and radiation therapy
What this could lead to
If successful, this combination could offer a more effective treatment option for locally advanced cervical cancer, potentially improving response rates and long-term survival.
What could go wrong
This is an early exploratory study with a small number of participants, so results may not be conclusive. The combination may cause unexpected side effects or not improve outcomes compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 31 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tianjin Cancer Hospital Airport Branch

    RECRUITING

    Tianjin, 300060, China

  • Tianjin Medical University Cancer Institute and Hospital

    RECRUITING

    Tianjin, 300060, China

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