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NCT06288373RecruitingPhase 2/3

Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC

Neoadjuvant Chemoimmunotherapy Combined With Surgery Versus Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer: a Multicenter Randomized Controlled Clinical Trial

Source: ClinicalTrials.gov · Last updated 30 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

It is a prospective, open-label, randomized, controlled phase II/III clinical trial in which patients with PD-L1-positive FIGO stage IB3, IIA2 and IIB(tumors \>4 cm in diameter)will be enrolled and randomly divided into the neoadjuvant chemoimmunotherapy plus surgery group and the CCRT group.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
440 (estimated)
First submitted
18 Feb 2024
Start date
22 Apr 2024
Primary completion date
1 Mar 2031
Lead sponsor
Tongji Hospital
NCT number
NCT06288373

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 440
  • From 22 Apr 2024 to the primary completion date, 1 Mar 2031
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; known hypersensitivity to any component of the study medication or other monoclonal antibodies;
  • Receipt of immunosuppressive medications or systemic corticosteroid therapy for immunosuppression (\>10 mg/day prednisone or equivalent) within 2 weeks prior to study dosing;
  • Diagnosed with another primary malignancy within 5 years prior to the first use of the investigational drug;
  • Received other investigational drugs/treatments or participated in another clinical trial within 4 weeks prior to randomization. Participation in observational and non-interventional clinical trials is allowed;
  • Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first dose of study drug; inactivated seasonal influenza virus vaccine is permitted;
  • Patients with a prior allogeneic bone marrow or solid organ transplant;
  • Drug and/or alcohol abuse;

Other illness

  • Any active autoimmune disease or history of autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention;
  • Has a history of human immunodeficiency virus (HIV) infection, active hepatitis B (HBV-DNA ≥ 2000 IU/mL or 104 copies/mL), and hepatitis C (HCV antibody positive, and HCV-RNA above the lower limit of detection of the assay);

Lab values

  • Uncontrolled co-morbidities, including but not limited to New York Heart Association (NYHA) class 2 or higher, severe/unstable angina pectoris, myocardial infarction within ≤ 6 months prior to study drug administration, severe arrhythmias requiring medication or intervention; difficult-to-control hypertension; cerebral vascular accidents or brain disorders within ≤ 6 months prior to study drug administration, or individuals with adjudicated abnormal behavioral skills; hematologic disorders: coagulation abnormalities (INR \>2. 0, PT\>16s), bleeding tendency, or undergoing thrombolytic or anticoagulant therapy; abnormalities in hepatic or renal development or a history of surgery; and development of an active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study drug;

Other

  • Pregnant or breastfeeding female patients;
  • Patients who, in the opinion of the investigator, are unlikely to comply with the procedures, restrictions, and requirements of the study may not be enrolled in the study.

Who the study is looking for

  • Locally advanced (2018 FIGO staged IB3, IIA2 and IIB(tumor size\> 4cm) ) cervical cancer,staging determined by two physicians of associate seniority or higher after gynecologic examination and imaging evaluation);
  • At least one measurable lesion at baseline according to RECIST 1.1 criteria, with lesion size based primarily on magnetic resonance imaging;
  • Pathologically confirmed diagnosis of cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma (common type), and adenosquamous carcinoma;
  • Positive PD-L1 expression, Combined Positive Score (CPS) ≥1;
  • Patient age ≥18 years and ≤70 years;
  • ECOG score ≤1;
  • Laboratory tests: WBC (white blood cell count) ≥ 3.5×109/L, NEU (neutrophil count) ≥ 1.5×109/L, PLT (platelet count) ≥ 100×109/L, total bilirubin ≤ 1.5 times the upper limit of normal, ALT (alanine aminotransferase) and AST (aspartate aminotransferase) ≤ 1.5 times the upper limit of normal, serum creatinine (BUN) ≤ 1.5 times the upper limit of normal or creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula, the Chronic Kidney Disease Epidemiology Collaboration equation, or the Modification of Diet in Renal Disease equation);
  • Be willing to follow up and good compliance;
  • Be willing to sign the informed consent, including compliance with the requirements and restrictions listed in the informed consent and program;
  • Agree to use effective contraception measures during the trial period and for 5 months after the last dose of pembrolizumab or 6 months after chemotherapy (whichever is longer).

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beiing Friendship Hospital, Capital Medical University
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BeijingChinaRecruiting
Xiangya Hospital Central South University
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ChangshaChinaRecruiting
Second People's Hospital of Sichuan (Sichuan Cancer Hospital)
Coordinator of this site? Confirm its status
ChengduChinaRecruiting
The First Affiliated Hospital (Southwest Hospital), Army Medical University (Third Military Medical University)
Coordinator of this site? Confirm its status
ChongqingChinaRecruiting
Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
Women's Hospital, Zhejiang University School of Medicine
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HangzhouChinaRecruiting
Anhui Provincial Cancer Hospital
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HefeiChinaRecruiting
Gansu Provincial Maternity and Child-care Hospital
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LanzhouChinaRecruiting
The Affiliated Tumor Hospital of Guangxi Medical University
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NanningChinaRecruiting
Shengjing Hospital Of China Medical University
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ShenyangChinaRecruiting
Tianjin Medical University General Hospital
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TianjinChinaRecruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Coordinator of this site? Confirm its status
WuhanChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.