Immunotherapy added to chemo aims to boost cervical cancer remission

NCT ID NCT07811375

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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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 Results may not be published yet.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

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are testing whether adding the immunotherapy drug adebrelimab to standard chemotherapy before and after surgery can improve outcomes for people with locally advanced cervical cancer. About 35 participants will receive three cycles of adebrelimab plus paclitaxel and cisplatin or carboplatin, then undergo surgery if the tumor is removable. After surgery, treatment continues with adebrelimab alone or with radiation, depending on each person's risk factors. The main goal is to see how many participants have no cancer left in the removed tissue.

What this could mean

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

Active substance
Adebrelimab, an immunotherapy drug, combined with paclitaxel and cisplatin chemotherapy
What this could lead to
If it works, this approach could become a new treatment option that helps more people with locally advanced cervical cancer achieve remission and avoid recurrence.
What could go wrong
This is a small, single-arm phase II trial, so any benefits seen may not hold up in larger studies. Adding immunotherapy to chemotherapy can also cause immune-related side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 35 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Aged 18 to 75 years. * Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix; FIGO 2018 stage IB3 or IIA2, or carefully selected stage IIB or IIIC1r disease following multidisciplinary team evaluation, with a maximum primary tumor diameter ≥4 cm. For participants with stage IIB or IIIC1r disease, PET/CT or an equivalent staging examination must exclude para-aortic lymph node metastasis and distant metastasis, and definitive concurrent chemoradiotherapy must remain feasible if neoadjuvant treatment is ineffective. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Able to provide adequate tumor tissue for biomarker testing, defined as at least 18 qualified tissue sections. * No prior surgery for cervical cancer, except staging procedures, and no prior radiotherapy, chemotherapy, systemic anticancer therapy, investigational therapy, or immunotherapy for cervical cancer. * At least one measurable lesion according to RECIST version 1.1, defined as a tumor lesion with a longest diameter ≥10 mm on CT or a lymph node with a short-axis diameter ≥15 mm on CT. * Estimated life expectancy ≥6 months. * No primary or metastatic central nervous system disease. * Adequate major organ function, meeting all of the following criteria: * No blood or blood-product transfusion within 14 days before assessment; * Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; * Platelet count ≥80 × 10⁹/L; * Hemoglobin ≥9 g/dL; * Total bilirubin \<1.5 × upper limit of normal (ULN); * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN; * Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥40 mL/min calculated using the Cockcroft-Gault formula. * Positive for high-risk human papillomavirus (HPV) DNA. * Written informed consent provided and willingness to comply with protocol-required follow-up. Exclusion Criteria: * Considered unsuitable for participation in the study by the investigator. * Known hypersensitivity or allergy to any study drug. * Any active, known, or suspected autoimmune disease, including but not limited to interstitial pneumonitis, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, or hypothyroidism; vitiligo; or asthma requiring medical intervention with bronchodilators. * Congenital or acquired immunodeficiency, including HIV infection, hepatitis B, or hepatitis C. * Prior treatment with PD-1 and/or PD-L1 inhibitors, CTLA-4 antibodies, or other agents targeting immune-regulatory receptors. * Current use of immunosuppressive agents. Patients in a stable condition who do not require systemic immunosuppressive therapy may be eligible. * Long-standing unhealed wounds or fractures; major surgery, severe traumatic injury, fracture, or ulcer within 4 weeks before initiation of study treatment. * Poorly controlled cardiac symptoms or cardiovascular disease, including New York Heart Association (NYHA) class III-IV heart failure or left ventricular ejection fraction (LVEF) \<50%; abnormal coagulation function defined as INR \>1.5 or APTT \>1.5 × ULN with a bleeding tendency; or an arterial or venous thromboembolic event within 6 months before the first dose of study treatment. * Symptomatic ascites, pleural effusion, or pericardial effusion requiring therapeutic puncture or drainage. Patients whose pleural or pericardial effusion remains stable for at least 2 weeks after drainage before the first dose of study treatment may be eligible. * Central nervous system metastases. * History of another malignancy, except for cured basal cell carcinoma of the skin or cervical carcinoma in situ. * Pregnant or breastfeeding women. * History of psychotropic drug abuse with inability to discontinue such use, or presence of a psychiatric disorder.

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Conditions

The condition(s) this trial relates to.

cervical cancer Neoplasm, Residual Pathologic Complete Response

As listed by the trial registrant

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

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Anhui province hospital

    Hefei, China

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