Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC
3 other identifiers
interventional
440
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2024
Longer than P75 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2024
CompletedFirst Posted
Study publicly available on registry
March 1, 2024
CompletedStudy Start
First participant enrolled
April 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2031
October 30, 2024
October 1, 2024
6.9 years
February 18, 2024
October 26, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Progression-free survival, PFS
PFS is defined as the time from randomisation to tumor progression, postoperative relaspse or metastasis, or death, which occur first.
7 years
Objective Response Rate, ORR
The proportion of patients who had either complete response or partial response, assessed by independent central reviewers according to RECIST, version 1.1.
2 years
Secondary Outcomes (7)
Overall survival, OS
7 years
Proportion of patients undergoing radical surgery
2 years
Pathologic Complete Response
2 years
The surgical complication rate
2 years
Safety and toleraty
7 years
- +2 more secondary outcomes
Study Arms (2)
Camrelizumab combined neoadjuvant chemotherapy plus radical surgery
EXPERIMENTALPatients 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).
Concurrent Chemoradiotherapy (CCRT)
ACTIVE COMPARATORPelvic EBRT + concurrent platinum-containing chemotherapy + brachytherapy
Interventions
Camrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery
Cisplatin：75-80mg/m2, D1-D2，q3w (3 cycles)，intravenous infusion, administered at a rate of 1mg/min.
Nab paclitaxel: 260 mg/m2，D1，q3w （3 cycles），intravenous infusion, administered over 30min.
Radical surgery
Radiation therapy per standard of care
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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;
- 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;
- 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);
- 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;
- Pregnant or breastfeeding female patients;
- 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;
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
- Southwest Hospital, Chinacollaborator
- Women's Hospital School Of Medicine Zhejiang Universitycollaborator
- Anhui Provincial Cancer Hospitalcollaborator
- Sichuan Cancer Hospital and Research Institutecollaborator
- Qilu Hospital of Shandong Universitycollaborator
- Beijing Friendship Hospitalcollaborator
- Tianjin Medical University General Hospitalcollaborator
- West China Second University Hospitalcollaborator
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universitycollaborator
- Xiangya Hospital of Central South Universitycollaborator
- Gansu Provincial Maternal and Child Health Care Hospitalcollaborator
- Zhejiang Cancer Hospitalcollaborator
- Shengjing Hospitalcollaborator
- Cancer Hospital of Guangxi Medical Universitycollaborator
Study Sites (12)
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000, China
Beiing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital (Southwest Hospital), Army Medical University (Third Military Medical University)
Chongqing, Chongqing Municipality, 400038, China
Gansu Provincial Maternity and Child-care Hospital
Lanzhou, Gansu, 730050, China
The Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Xiangya Hospital, Central South University
Changsha, Hunan, 410008, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Second People's Hospital of Sichuan (Sichuan Cancer Hospital)
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310022, China
Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ding Ma
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
February 18, 2024
First Posted
March 1, 2024
Study Start
April 22, 2024
Primary Completion (Estimated)
March 1, 2031
Study Completion (Estimated)
March 1, 2031
Last Updated
October 30, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share