Under construction – not a live service
Sign in
Taking people in ChinaPhase 2/3

Compares chemoimmunotherapy before surgery with chemoradiotherapy for cervical cancer

Compares pre-surgery chemoimmunotherapy with chemoradiotherapy in adults with locally advanced cervical cancer.

Key facts

Who runs it
Tongji Hospital
Where
Beijing, Changsha, Chengdu, Chongqing, Hangzhou, Hefei, Lanzhou, Nanning, Shenyang, Tianjin, and Wuhan, ChinaSee the 12 sites
Trial code
Registry title
Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC
Status
Recruiting
Phase
Phase 2/3
People taking part
440 people, planned
Started
22 Apr 2024
Expected to end
1 Mar 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Camrelizumab
  • Cisplatin
  • Nab paclitaxel
  • Radical surgery
  • external beam radiation therapy (EBRT) + brachytherapy
Record updated
30 October 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 18 to 70 with locally advanced cervical cancer whose tumour tests PD-L1 positive (CPS ≥1). It compares chemotherapy plus immunotherapy followed by surgery with chemotherapy given together with radiation.

Age
18 to 70 years
Sex
Women only
Disease stage
Locally advanced cervical cancer, FIGO 2018 stage IB3, IIA2 or IIB (tumour larger than 4 cm (1.6 in)). Confirmed squamous cell carcinoma, adenocarcinoma (common type) or adenosquamous carcinoma. At least one lesion that can be measured (RECIST 1.1).
Earlier treatment
People who have had immune checkpoint inhibitors (such as anti-PD-1 or anti-PD-L1 antibodies) cannot join.
Biomarker or test result
PD-L1 positive, Combined Positive Score (CPS) ≥1.

Main reasons for not taking part

  • Active autoimmune disease, or past autoimmune disease needing systemic treatment
  • Previous treatment with an immune checkpoint inhibitor
  • HIV infection history, active hepatitis B or hepatitis C
  • Pregnant or breastfeeding
  • Previous bone marrow or solid organ transplant

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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
  • 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)
  • 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
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Where in China

  • Beiing Friendship Hospital, Capital Medical UniversityBeijing, ChinaContact: Zhiqi Wang, PhDTaking people
  • Xiangya Hospital Central South UniversityChangsha, ChinaContact: Yu Zhang, PhDTaking people
  • Second People's Hospital of Sichuan (Sichuan Cancer Hospital)Chengdu, ChinaContact: Dengfeng Wang, PhDTaking people
  • The First Affiliated Hospital (Southwest Hospital), Army Medical University (Third Military Medical University)Chongqing, ChinaContact: Yanzhou Wang, PhDTaking people
  • Women's Hospital, Zhejiang University School of MedicineHangzhou, ChinaContact: Yuanming Shen, PhDTaking people
  • Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of SciencesHangzhou, ChinaContact: Yingli Zhang, PhDTaking people
  • Anhui Provincial Cancer HospitalHefei, ChinaContact: Bairong Xia, PhDTaking people
  • Gansu Provincial Maternity and Child-care HospitalLanzhou, ChinaContact: Yun Dang, PhDTaking people
  • The Affiliated Tumor Hospital of Guangxi Medical UniversityNanning, ChinaContact: Ying Long, PhDTaking people
  • Shengjing Hospital Of China Medical UniversityShenyang, ChinaContact: Tingting Gong, PhDTaking people
  • Tianjin Medical University General HospitalTianjin, ChinaContact: Yingmei Wang, PhDTaking people
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaContact: Kezhen LiTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Camrelizumab combined neoadjuvant chemotherapy plus radical surgeryTreatment being tested

    Patients receive 1 cycle of cisplatin and nab paclitaxel combined neoadjuvant chemotherapy and subsequent 2 cycles of camrelizumab combined neoadjuvant chemotherapy. Based on the tumor size as indicated by MRI, patients who achieve complete response or partial response (CR/PR,RECIST v1.1) will undergo open radical hysterectomy and pelvic lymph node dissection. Patients who show stable disease or progression (SD/PD,v1.1) will proceed directly to concurrent chemoradiotherapy (CCRT).

    Treatment: Camrelizumab, Cisplatin, Nab paclitaxel, and Radical surgery

  • Concurrent Chemoradiotherapy (CCRT)Existing treatment, for comparison

    Pelvic EBRT + concurrent platinum-containing chemotherapy + brachytherapy

    Treatment: external beam radiation therapy (EBRT) + brachytherapy and Cisplatin

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Neoadjuvant Chemoimmunotherapy Combined With Surgery Versus Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer: a Multicenter Randomized Controlled Clinical Trial
Plain-language title
Compares chemoimmunotherapy before surgery with chemoradiotherapy for cervical cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06288373, who can take part
Record updated
30 October 2024