Perioperative Adebrelimab for Locally Advanced Cervical Cancer (ADE-LACC)

September 3, 2026 updated by: Anhui Provincial Hospital

A Single-Center, Single-Arm, Phase II Study of Perioperative Adebrelimab Combined With Neoadjuvant Paclitaxel and Platinum Chemotherapy in Locally Advanced Cervical Cancer

This prospective, single-center, single-arm, phase II study will evaluate perioperative adebrelimab in patients with locally advanced cervical cancer. Approximately 35 participants will receive three 3-week cycles of neoadjuvant adebrelimab in combination with paclitaxel and cisplatin or carboplatin. Participants without disease progression who are considered resectable will undergo radical hysterectomy and pelvic lymph node dissection 28-42 days after the last cycle of neoadjuvant treatment.

Postoperative treatment will be risk-adapted according to pathological risk factors. Participants with high-risk pathological factors will discontinue protocol treatment and receive standard concurrent chemoradiotherapy. Participants with intermediate-risk factors will receive guideline-recommended pelvic radiotherapy plus adebrelimab maintenance, whereas low-risk participants will receive adebrelimab maintenance. Adebrelimab maintenance will be administered every 3 weeks for up to 1 year and may be discontinued early after two consecutive negative circulating tumor HPV DNA tests at least 3 months apart.

The primary endpoint is the pathologic complete response rate. Secondary endpoints include objective response rate, disease control rate, disease-free survival, 2-year disease-free survival rate, overall survival, duration of response, quality of life, and safety. Dynamic circulating tumor HPV DNA will also be explored as a biomarker of treatment response and postoperative recurrence risk.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Adebrelimab Plus Paclitaxel and Platinum-Based Chemotherapy
Participants will receive three cycles of neoadjuvant adebrelimab (1200 mg intravenously every 3 weeks) plus paclitaxel (175 mg/m² intravenously every 3 weeks) and cisplatin (70-75 mg/m² intravenously every 3 weeks) or carboplatin (AUC 5 intravenously every 3 weeks). Participants considered suitable for R0 resection will undergo radical hysterectomy and pelvic lymph node dissection 28-42 days after the last neoadjuvant cycle. Postoperative management will be risk-adapted. Eligible intermediate- and low-risk participants will receive adebrelimab maintenance every 3 weeks for up to 1 year, with early discontinuation permitted after two consecutive negative ctHPV DNA tests at least 3 months apart
Drug: Adebrelimab
debrelimab 1200 mg will be administered intravenously every 3 weeks for three cycles during neoadjuvant treatment. Eligible participants will subsequently receive postoperative adebrelimab maintenance at 1200 mg intravenously every 3 weeks for up to 1 year, or until protocol-defined discontinuation criteria are met.
Drug: Paclitaxel
Paclitaxel 175 mg/m² will be administered intravenously every 3 weeks for three cycles as part of neoadjuvant treatment.
Drug: Cisplatin
Cisplatin 70-75 mg/m² will be administered intravenously every 3 weeks for three cycles as a platinum option during neoadjuvant treatment.
Drug: Carboplatin (AUC 5)
Carboplatin AUC 5 will be administered intravenously every 3 weeks for three cycles as an alternative platinum option during neoadjuvant treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pathologic Complete Response (pCR) Rate
Time Frame: At definitive surgery, planned 28-42 days after completion of the third cycle of neoadjuvant treatment (approximately 10-12 weeks after initiation of treatment)
The proportion of participants achieving pathologic complete response following neoadjuvant treatment. pCR is defined as no residual invasive carcinoma in the cervical primary tumor and no metastatic carcinoma in any resected regional lymph node, with ypT0/is ypN0 used as the operational definition. The primary analysis denominator will include all participants who receive at least one dose of study treatment. Participants who do not undergo surgery, experience disease progression, withdraw, die, or have missing primary endpoint data will be considered not to have achieved pCR.
At definitive surgery, planned 28-42 days after completion of the third cycle of neoadjuvant treatment (approximately 10-12 weeks after initiation of treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From baseline to preoperative tumor assessment after completion of three cycles of neoadjuvant treatment, approximately 9 weeks
Proportion of participants achieving complete response or partial response according to RECIST version 1.1.
From baseline to preoperative tumor assessment after completion of three cycles of neoadjuvant treatment, approximately 9 weeks
Disease Control Rate (DCR)
Time Frame: From baseline to preoperative tumor assessment after completion of three cycles of neoadjuvant treatment, approximately 9 weeks
Proportion of participants achieving complete response, partial response, or stable disease according to RECIST version 1.1.
From baseline to preoperative tumor assessment after completion of three cycles of neoadjuvant treatment, approximately 9 weeks
Disease-Free Survival (DFS)
Time Frame: From definitive surgery to disease recurrence, death, or last disease-free follow-up, assessed through December 31, 2029
Time from definitive surgery to the first documented disease recurrence or death from any cause, whichever occurs first. Participants without an event will be censored at the date of the last known disease-free assessment.
From definitive surgery to disease recurrence, death, or last disease-free follow-up, assessed through December 31, 2029
Two-Year Disease-Free Survival Rate
Time Frame: 2 years after definitive surgery
Proportion of participants alive and free of disease recurrence 2 years after definitive surgery.
2 years after definitive surgery
Overall Survival (OS)
Time Frame: From first study treatment to death or last known alive, assessed through December 31, 2029
Time from the first administration of study treatment to death from any cause. Participants alive at the time of analysis will be censored at the date last known alive.
From first study treatment to death or last known alive, assessed through December 31, 2029
Duration of Response (DOR)
Time Frame: From first documented CR or PR to disease progression or death, assessed through December 31, 2029
Among participants who achieve a complete or partial response, duration from the first documented response to disease progression or death before progression.
From first documented CR or PR to disease progression or death, assessed through December 31, 2029
Incidence of Adverse Events
Time Frame: From the first dose of study treatment through 90 days after the last dose or initiation of a new anticancer treatment, whichever occurs first
Incidence and severity of adverse events, treatment-emergent adverse events, and serious adverse events, graded according to NCI CTCAE version 5.0.
From the first dose of study treatment through 90 days after the last dose or initiation of a new anticancer treatment, whichever occurs first
ORTC QLQ-C30 Scores Outcome
Time Frame: Baseline and at the end of each 21-day treatment cycle during study treatment, through completion of study treatment, up to 1 year
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) is a 30-item questionnaire used to assess health-related quality of life in patients with cancer. Scores for each scale are linearly transformed to a range from 0 to 100. Higher scores on the functional scales and the global health status/quality-of-life scale indicate better functioning or quality of life, whereas higher scores on the symptom scales and single symptom items indicate greater symptom severity or problems. Change from baseline in EORTC QLQ-C30 scores will be assessed during study treatment.
Baseline and at the end of each 21-day treatment cycle during study treatment, through completion of study treatment, up to 1 year
EORTC QLQ-CX24 Outcome
Time Frame: Baseline and at the end of each 21-day treatment cycle during study treatment, through completion of study treatment, up to 1 year
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module 24 (EORTC QLQ-CX24) Scores. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module 24 (EORTC QLQ-CX24) is a 24-item cervical cancer-specific quality-of-life questionnaire used in conjunction with the EORTC QLQ-C30. It assesses symptom experience, body image, sexual/vaginal functioning, lymphedema, peripheral neuropathy, menopausal symptoms, sexual worry, sexual activity, and sexual enjoyment. All scale and single-item scores are linearly transformed to a range from 0 to 100. Higher scores on symptom scales/items indicate greater symptom severity or problems, whereas higher scores for the functional items of sexual activity and sexual enjoyment indicate better functioning. Change from baseline in EORTC QLQ-CX24 scores will be assessed during study treatment.
Baseline and at the end of each 21-day treatment cycle during study treatment, through completion of study treatment, up to 1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ctHPV DNA Dynamics and Pathologic Response
Time Frame: At baseline, before surgery, and approximately 2 weeks after surgery
Changes in circulating tumor HPV DNA status and levels from baseline to the preoperative and postoperative time points will be evaluated for their association with pathologic complete response.
At baseline, before surgery, and approximately 2 weeks after surgery
ctHPV DNA Dynamics and Disease-Free Survival
Time Frame: From baseline through maintenance treatment, with assessments every 3 months for up to 1 year after surgery
The association between longitudinal ctHPV DNA status and subsequent disease-free survival and 2-year disease-free survival will be explored. During maintenance treatment, ctHPV DNA will be assessed every 3 months. Two consecutive negative tests at least 3 months apart will define sustained molecular residual disease negativity according to the protocol.
From baseline through maintenance treatment, with assessments every 3 months for up to 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anhui Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Zhouying-ZAT-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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