Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC
NCT ID: NCT06288373
Last Updated: 2024-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
440 participants
INTERVENTIONAL
2024-04-22
2031-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Camrelizumab combined neoadjuvant chemotherapy plus radical surgery
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).
Camrelizumab
Camrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery
Cisplatin
Cisplatin：75-80mg/m2, D1-D2，q3w (3 cycles)，intravenous infusion, administered at a rate of 1mg/min.
Nab paclitaxel
Nab paclitaxel: 260 mg/m2，D1，q3w （3 cycles），intravenous infusion, administered over 30min.
Radical surgery
Radical surgery
Concurrent Chemoradiotherapy (CCRT)
Pelvic EBRT + concurrent platinum-containing chemotherapy + brachytherapy
external beam radiation therapy (EBRT) + brachytherapy
Radiation therapy per standard of care
Cisplatin
Chemotherapy administered concurrent with radiation therapy，cisplatin 40 mg/m2 IV once per week (QW) for 5 weeks
Interventions
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Camrelizumab
Camrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery
Cisplatin
Cisplatin：75-80mg/m2, D1-D2，q3w (3 cycles)，intravenous infusion, administered at a rate of 1mg/min.
Nab paclitaxel
Nab paclitaxel: 260 mg/m2，D1，q3w （3 cycles），intravenous infusion, administered over 30min.
Radical surgery
Radical surgery
external beam radiation therapy (EBRT) + brachytherapy
Radiation therapy per standard of care
Cisplatin
Chemotherapy administered concurrent with radiation therapy，cisplatin 40 mg/m2 IV once per week (QW) for 5 weeks
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
FEMALE
No
Sponsors
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Southwest Hospital, China
OTHER
Women's Hospital School Of Medicine Zhejiang University
OTHER
Anhui Provincial Cancer Hospital
OTHER
Sichuan Cancer Hospital and Research Institute
OTHER
Qilu Hospital of Shandong University
OTHER
Beijing Friendship Hospital
OTHER
Tianjin Medical University General Hospital
OTHER
West China Second University Hospital
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Xiangya Hospital of Central South University
OTHER
Gansu Provincial Maternal and Child Health Care Hospital
OTHER
Zhejiang Cancer Hospital
OTHER
Shengjing Hospital
OTHER
Cancer Hospital of Guangxi Medical University
OTHER
Tongji Hospital
OTHER
Responsible Party
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Kezhen Li
Prof
Principal Investigators
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Ding Ma
Role: STUDY_CHAIR
Tongji Hospital
Locations
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Anhui Provincial Cancer Hospital
Hefei, Anhui, 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, China
Gansu Provincial Maternity and Child-care Hospital
Lanzhou, Gansu, China
The Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Second People's Hospital of Sichuan (Sichuan Cancer Hospital)
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Yun Dang, PhD
Role: primary
Ying Long, PhD
Role: primary
Dengfeng Wang, PhD
Role: primary
Other Identifiers
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MA-CERVC-II/III-006
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
[2024](S018)
Identifier Type: OTHER
Identifier Source: secondary_id
NACI-CERV-003
Identifier Type: -
Identifier Source: org_study_id
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