To hear about similar clinical trials, please enter your email below

Trial Title: Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC

NCT ID: NCT06288373

Condition: Cervical Cancer
Locally Advanced Cervical Cancer
Concurrent Chemoradiotherapy
Neoadjuvant Chemoimmunotherapy

Conditions: Official terms:
Uterine Cervical Neoplasms
Paclitaxel
Cisplatin

Study type: Interventional

Study phase: Phase 2/Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Camrelizumab
Description: Camrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery
Arm group label: Camrelizumab combined neoadjuvant chemotherapy plus radical surgery

Intervention type: Drug
Intervention name: Cisplatin
Description: Cisplatin:75-80mg/m2, D1-D2,q3w (3 cycles),intravenous infusion, administered at a rate of 1mg/min.
Arm group label: Camrelizumab combined neoadjuvant chemotherapy plus radical surgery

Intervention type: Drug
Intervention name: Nab paclitaxel
Description: Nab paclitaxel: 260 mg/m2,D1,q3w (3 cycles),intravenous infusion, administered over 30min.
Arm group label: Camrelizumab combined neoadjuvant chemotherapy plus radical surgery

Intervention type: Procedure
Intervention name: Radical surgery
Description: Radical surgery
Arm group label: Camrelizumab combined neoadjuvant chemotherapy plus radical surgery

Intervention type: Radiation
Intervention name: external beam radiation therapy (EBRT) + brachytherapy
Description: Radiation therapy per standard of care
Arm group label: Concurrent Chemoradiotherapy (CCRT)

Intervention type: Drug
Intervention name: Cisplatin
Description: Chemotherapy administered concurrent with radiation therapy,cisplatin 40 mg/m2 IV once per week (QW) for 5 weeks
Arm group label: Concurrent Chemoradiotherapy (CCRT)

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.

Detailed description: Cervical cancer is the most common gynecological malignancy in China, with locally advanced cervical cancer (LACC) accounting for approximately 37% of cases. Currently, the recommended standard of care for LACC according to international guidelines is concurrent chemoradiotherapy (CCRT). However, the impacts of radiation therapy on patients' quality of life are increasingly being recognized. Additionally, 23.3% to 34.4% of patients still face recurrence or metastasis after treatment, and the 5-year overall survival rate remains around 75%. Neoadjuvant chemotherapy (NACT) is a chemotherapy regimen used prior to surgery for LACC. NACT followed by radical surgery has a similar overall survival compared to CCRT, but the disease-free survival is relatively lower with NACT. Moreover, 9.8% to 30.6% of patients show poor response to NACT, and over 30% of patients require postoperative adjuvant therapy. These issues significantly limit the application of NACT in LACC. In recent years, immunotherapy has made significant progress in advanced or recurrent cervical cancer. A phase II clinical trial of combination of PD-1 inhibitors and neoadjuvant chemotherapy showed significant anti-tumor activity and safety. Therefore, based on the preliminary results, this project aims to conduct a multicenter, prospective, randomized controlled clinical trial to further confirm the value of neoadjuvant immunotherapy combined with surgery in LACC. It will be compared with the standard CCRT regimen to explore the differences in clinical efficacy and adverse events between the two groups, providing high-level evidence for the application of neoadjuvant immunotherapy in cervical cancer.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. 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); 2. At least one measurable lesion at baseline according to RECIST 1.1 criteria, with lesion size based primarily on magnetic resonance imaging; 3. Pathologically confirmed diagnosis of cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma (common type), and adenosquamous carcinoma; 4. Positive PD-L1 expression, Combined Positive Score (CPS) ≥1; 5. Patient age ≥18 years and ≤70 years; 6. ECOG score ≤1; 7. 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); 8. Be willing to follow up and good compliance; 9. Be willing to sign the informed consent, including compliance with the requirements and restrictions listed in the informed consent and program; 10. 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). Exclusion Criteria: 1. 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; 2. 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; 3. 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); 4. Receipt of immunosuppressive medications or systemic corticosteroid therapy for immunosuppression (>10 mg/day prednisone or equivalent) within 2 weeks prior to study dosing; 5. Diagnosed with another primary malignancy within 5 years prior to the first use of the investigational drug; 6. 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; 7. Pregnant or breastfeeding female patients; 8. 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; 9. 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; 10. Patients with a prior allogeneic bone marrow or solid organ transplant; 11. Drug and/or alcohol abuse; 12. 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.

Gender: Female

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Anhui Provincial Cancer Hospital

Address:
City: Hefei
Zip: 230000
Country: China

Status: Recruiting

Contact:
Last name: Bairong Xia, PhD
Email: xiabairong@ustc.edu.cn

Investigator:
Last name: Bairong Bairong, PhD
Email: Principal Investigator

Facility:
Name: Beiing Friendship Hospital, Capital Medical University

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:
Last name: Zhiqi Wang, PhD
Email: wangzqnet@sina.com

Investigator:
Last name: Zhiqi Zhiqi, PhD
Email: Principal Investigator

Facility:
Name: The First Affiliated Hospital (Southwest Hospital), Army Medical University (Third Military Medical University)

Address:
City: Chongqing
Zip: 400038
Country: China

Status: Recruiting

Contact:
Last name: Yanzhou Wang, PhD
Email: w.y.z@foxmail.com

Investigator:
Last name: Yanzhou Yanzhou, PhD
Email: Principal Investigator

Facility:
Name: Gansu Provincial Maternity and Child-care Hospital

Address:
City: Lanzhou
Zip: 730050
Country: China

Status: Recruiting

Contact:
Last name: Yun Dang, PhD

Investigator:
Last name: Yun Dang, PhD
Email: Principal Investigator

Facility:
Name: The Affiliated Tumor Hospital of Guangxi Medical University

Address:
City: Nanning
Zip: 530021
Country: China

Status: Recruiting

Contact:
Last name: Ying Long, PhD

Investigator:
Last name: Ying Long, PhD
Email: Principal Investigator

Facility:
Name: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address:
City: Wuhan
Zip: 430030
Country: China

Status: Recruiting

Contact:
Last name: Kezhen Li

Phone: 086-027-8362
Email: tjkeke@126.com

Contact backup:
Last name: Jing Chen

Phone: 086-027-8362
Email: chenjing3223@126.com

Investigator:
Last name: Kezhen Li
Email: Principal Investigator

Investigator:
Last name: Gang Chen
Email: Principal Investigator

Facility:
Name: Xiangya Hospital, Central South University

Address:
City: Changsha
Zip: 410008
Country: China

Status: Recruiting

Contact:
Last name: Yu Zhang, PhD
Email: xyzhangyu@csu.edu.cn

Investigator:
Last name: Yu Zhang, PhD
Email: Principal Investigator

Facility:
Name: Shengjing Hospital of China Medical University

Address:
City: Shenyang
Country: China

Status: Recruiting

Contact:
Last name: Tingting Gong, PhD
Email: gongtt@sj-hospital.org

Investigator:
Last name: Tingting Gong, PhD
Email: Principal Investigator

Facility:
Name: Second People's Hospital of Sichuan (Sichuan Cancer Hospital)

Address:
City: Chengdu
Zip: 610041
Country: China

Status: Recruiting

Contact:
Last name: Dengfeng Wang, PhD

Investigator:
Last name: Dengfeng Wang, PhD
Email: Principal Investigator

Facility:
Name: Tianjin Medical University General Hospital

Address:
City: Tianjin
Country: China

Status: Recruiting

Contact:
Last name: Yingmei Wang, PhD
Email: wangyingmei@tmu.edu.cn

Investigator:
Last name: Yingmei Yingmei, PhD
Email: Principal Investigator

Facility:
Name: Women's Hospital, Zhejiang University School of Medicine

Address:
City: Hangzhou
Zip: 310022
Country: China

Status: Recruiting

Contact:
Last name: Yuanming Shen, PhD
Email: 5312010@zju.edu.cn

Investigator:
Last name: Yuanming Shen, PhD
Email: Principal Investigator

Facility:
Name: Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences

Address:
City: Hangzhou
Zip: 310022
Country: China

Status: Recruiting

Contact:
Last name: Yingli Zhang, PhD
Email: zhangyl@zjcc.org.cn

Investigator:
Last name: Yingli Zhang, PhD
Email: Principal Investigator

Start date: April 22, 2024

Completion date: March 1, 2031

Lead sponsor:
Agency: Tongji Hospital
Agency class: Other

Collaborator:
Agency: Southwest Hospital, China
Agency class: Other

Collaborator:
Agency: Women Hospital, School of Medicine, Zhejiang University
Agency class: Other

Collaborator:
Agency: Anhui Provincial Cancer Hospital
Agency class: Other

Collaborator:
Agency: Sichuan Cancer Hospital and Research Institute
Agency class: Other

Collaborator:
Agency: Qilu Hospital of Shandong University
Agency class: Other

Collaborator:
Agency: Beijing Friendship Hospital
Agency class: Other

Collaborator:
Agency: Tianjin Medical University General Hospital
Agency class: Other

Collaborator:
Agency: West China Second University Hospital
Agency class: Other

Collaborator:
Agency: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class: Other

Collaborator:
Agency: Xiangya Hospital of Central South University
Agency class: Other

Collaborator:
Agency: Gansu Provincial Maternal and Child Health Care Hospital
Agency class: Other

Collaborator:
Agency: Zhejiang Cancer Hospital
Agency class: Other

Collaborator:
Agency: Shengjing Hospital
Agency class: Other

Collaborator:
Agency: Cancer Hospital of Guangxi Medical University
Agency class: Other

Source: Tongji Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06288373

Login to your account

Did you forget your password?