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Locally Advanced Cervical CancerPhase 2ADE-LACCNCT07811375

Perioperative Adebrelimab for Locally Advanced Cervical Cancer

A Phase 2 study testing Adebrelimab, Paclitaxel and Cisplatin in people with Locally Advanced Cervical Cancer, run by Anhui Provincial Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Locally Advanced Cervical Cancer
What is being tested?
Adebrelimab, Paclitaxel and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
1 Oct 2026to 31 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Anhui province hospital

    Hefei

    Yi Liu, +8615755149324, liuyi0428@mail.ustc.edu.cn

Other trials in China

About this study

Official title: 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.

Being tested
Adebrelimab, Paclitaxel, Cisplatin, Carboplatin (AUC 5)
Keywords
Locally advanced cervical cancer, Adebrelimab, Neoadjuvant therapy, Pathologic complete response, Circulating tumor human papillomavirus DNA, Minimal residual disease
Medical subject headings
Pathologic Complete Response, Neoplasm, Residual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdebrelimabDrug

    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.

  • PaclitaxelDrug

    Paclitaxel 175 mg/m² will be administered intravenously every 3 weeks for three cycles as part of neoadjuvant treatment.

  • CisplatinDrug

    Cisplatin 70-75 mg/m² will be administered intravenously every 3 weeks for three cycles as a platinum option during neoadjuvant treatment.

  • Carboplatin (AUC 5)Drug

    Carboplatin AUC 5 will be administered intravenously every 3 weeks for three cycles as an alternative platinum option during neoadjuvant treatment.

Study groups in NCT07811375
Study groupRoleWhat they receive
Adebrelimab Plus Paclitaxel and Platinum-Based ChemotherapyExperimentalParticipants 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
Receives: Drug: Adebrelimab; Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin (AUC 5)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic Complete Response (pCR) Rate

    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.

    Measured: 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 outcomes (9)
  1. Objective Response Rate (ORR)

    Proportion of participants achieving complete response or partial response according to RECIST version 1.1.

    Measured: From baseline to preoperative tumor assessment after completion of three cycles of neoadjuvant treatment, approximately 9 weeks

  2. Disease Control Rate (DCR)

    Proportion of participants achieving complete response, partial response, or stable disease according to RECIST version 1.1.

    Measured: From baseline to preoperative tumor assessment after completion of three cycles of neoadjuvant treatment, approximately 9 weeks

  3. Disease-Free Survival (DFS)

    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.

    Measured: From definitive surgery to disease recurrence, death, or last disease-free follow-up, assessed through December 31, 2029

  4. Two-Year Disease-Free Survival Rate

    Proportion of participants alive and free of disease recurrence 2 years after definitive surgery.

    Measured: 2 years after definitive surgery

  5. Overall Survival (OS)

    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.

    Measured: From first study treatment to death or last known alive, assessed through December 31, 2029

  6. Duration of Response (DOR)

    Among participants who achieve a complete or partial response, duration from the first documented response to disease progression or death before progression.

    Measured: From first documented CR or PR to disease progression or death, assessed through December 31, 2029

  7. Incidence of Adverse Events

    Incidence and severity of adverse events, treatment-emergent adverse events, and serious adverse events, graded according to NCI CTCAE version 5.0.

    Measured: From the first dose of study treatment through 90 days after the last dose or initiation of a new anticancer treatment, whichever occurs first

  8. ORTC QLQ-C30 Scores Outcome

    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.

    Measured: Baseline and at the end of each 21-day treatment cycle during study treatment, through completion of study treatment, up to 1 year

  9. EORTC QLQ-CX24 Outcome

    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.

    Measured: Baseline and at the end of each 21-day treatment cycle during study treatment, through completion of study treatment, up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will receive three cycles of neoadjuvant adebrelimab plus paclitaxel and cisplatin or carboplatin every 3 weeks. Participants considered resectable after neoadjuvant treatment will undergo radical hysterectomy and pelvic lymph node dissection 28-42 days after the last neoadjuvant cycle. Postoperative treatment will be determined by pathological risk factors. High-risk participants will discontinue protocol treatment and receive standard concurrent chemoradiotherapy; intermediate-risk participants will receive pelvic radiotherapy plus adebrelimab maintenance; and low-risk participants will receive adebrelimab maintenance. Maintenance adebrelimab will continue every 3 weeks for up to 1 year and may be stopped early after two consecutive negative ctHPV DNA tests at least 3 months apart.
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07811375
Sponsor's protocol ID
Zhouying-ZAT-2
Acronym
ADE-LACC
Status last verified
Aug 2026
First submitted
17 Aug 2026
Last updated
10 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adebrelimab, Paclitaxel and Cisplatin in people with Locally Advanced Cervical Cancer, run by Anhui Provincial Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ying Zhou (0551-62283954, caddiezy@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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