Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer
NCT ID: NCT06289062
Last Updated: 2024-11-05
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
40 participants
INTERVENTIONAL
2024-05-08
2030-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NACI in FIGO ⅠB1 Cervical Cancer
Neoadjuvant chemotherapy plus camrelizumab for ⅠB1 Cervical Cancer. Patients first received one cycle of platinum-based doublet priming chemotherapy. After 3 weeks, participants subsequently received two cycles of the PD-1 inhibitor camrelizumab combined with chemotherapy every 3 weeks. The study will be conducted in two stages: (1) Patients enrolled in the first stage with tumors ≤2 cm and no new lesions after completion of treatment will undergo cone biopsy + pelvic lymphadenectomy or SLN mapping. Those who meet ConCerv criteria will undergo a second TCT, human papillomavirus (HPV) and colposcope 3 months later, and those who do not meet ConCerV criteria will undergo radical cervical surgery. (2) Patients enrolled in the second stage with tumors ≤2 cm and no new lesions underwent cervical biopsy + pelvic lymphadenectomy or SLN mapping; patients with LSIL on biopsy underwent TCT, HPV, and colposcope 3 months later; if biopsy suggests HSIL and above, perform cone biopsy.
Camrelizumab
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.
biopsy
cone biopsy + pelvic lymphadenectomy or Cervical biopsy + pelvic lymphadenectomy
Interventions
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Camrelizumab
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.
biopsy
cone biopsy + pelvic lymphadenectomy or Cervical biopsy + pelvic lymphadenectomy
Eligibility Criteria
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Inclusion Criteria
2. Pathologically confirmed diagnosis of cervical squamous cell carcinoma;
3. Transformation zone of TZ1 or TZ2 (IFCPC 2011);
4. Positive PD-L1 expression by preoperative pathology, i.e., Combined Positive Score (CPS) ≥1;
5. Patient age ≥18 years and ≤45 years;
6. ECOG score ≤1;
7. Laboratory tests: white blood cell (WBC) ≥3. 5×109/L, Neutrophil (NEU) ≥1. 5×109/L, platelet (PLT) ≥100×109/L, serum bilirubin ≤1.5 times the upper limit of normal, aminotransferase ≤1.5 times the upper limit of normal, and blood urea nitrogen （BUN) and Cr ≤normal;
8. Have a strong desire to give birth;
9. Willing to sign the informed consent form, including compliance with the requirements and restrictions listed in the informed consent form and program.
Exclusion Criteria
2. Any active autoimmune disease or history of autoimmune disease requiring systemic treatment, including, but not limited to, autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention;
3. 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;
4. History of human immunodeficiency virus (HIV) infection or known active hepatitis B or C;
5. Use of immunosuppressive drugs or systemic corticosteroid therapy for immunosuppression (\>10 mg/day prednisone or equivalent) within 2 weeks prior to study dosing;
6. History of primary malignancy or receipt of chemotherapy or pelvic radiation;
7. Concurrent participation in other clinical trials;
8. Pregnant or breastfeeding female patients; subjects must agree to use effective contraception during study treatment, within 5 months of last use of immune check inhibitors, within 6 months of last use of chemotherapeutic agents, and if there is no confirmation that the lesion has been removed or that the pathology is in remission;
9. 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; and cerebral vascular accidents or brain disorders within ≤ 6 months prior to study drug administration, or those with adjudicated abnormal behavioral skills; hematologic disorders: coagulation abnormalities (INR \> 2. 0, Prothrombin time (PT) \> 16s), bleeding tendency, or undergoing thrombolytic or anticoagulant therapy; abnormalities in hepatic or renal development or a history of surgery; and any active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study drug;
10. Treatment with live or attenuated vaccine within 4 weeks prior to the first dose of study drug; inactivated seasonal influenza virus vaccine is permitted;
11. Patients who have received a previous allogeneic bone marrow or solid organ transplant;
12. Drug and/or alcohol abuse;
13. Patients who, in the opinion of the investigator, are unlikely to comply with the study procedures, restrictions, and requirements may not participate in this study.
18 Years
45 Years
FEMALE
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Women's Hospital School Of Medicine Zhejiang University
OTHER
Third Military Medical University
OTHER
Beijing Friendship Hospital
OTHER
Sichuan Cancer Hospital and Research Institute
OTHER
Tianjin Medical University
OTHER
West China Second University Hospital
OTHER
Xiangya Hospital of Central South University
OTHER
Qilu Hospital of Shandong University
OTHER
Gansu Cancer Hospital
OTHER
Zhejiang Cancer Hospital
OTHER
Shengjing Hospital
OTHER
Anhui Provincial Cancer Hospital
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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Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NACI-CERV-005
Identifier Type: -
Identifier Source: org_study_id
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