Immunotherapy added to chemo aims to boost cervical cancer remission
NCT ID NCT07811375
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Anhui province hospital
Hefei, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Double-Target immunotherapy added to standard care for aggressive cervical cancer
- Could vitamin d predict cervical cancer treatment success?
- Can a triple-threat approach wipe out cervical cancer before surgery?
- Particle beam and immune therapy join forces against cervical cancer
- Dual immunotherapy plus chemo may shrink cervical tumors before surgery
- Protein clues may predict cervical cancer return