Trial Title:
Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer
NCT ID:
NCT06289062
Condition:
Cervical Cancer
Neoadjuvant Chemoimmunotherapy
Fertility Preservation
Conditions: Official terms:
Uterine Cervical Neoplasms
Paclitaxel
Cisplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group 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:
NACI in FIGO ⅠB1 Cervical Cancer
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
75-80mg/m2, D1-D2,q3w (3 cycles),intravenous infusion, administered at a rate of 1mg/min.
Arm group label:
NACI in FIGO ⅠB1 Cervical Cancer
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
260 mg/m2,D1,q3w (3 cycles),intravenous infusion, administered over 30min.
Arm group label:
NACI in FIGO ⅠB1 Cervical Cancer
Intervention type:
Procedure
Intervention name:
biopsy
Description:
cone biopsy + pelvic lymphadenectomy or Cervical biopsy + pelvic lymphadenectomy
Arm group label:
NACI in FIGO ⅠB1 Cervical Cancer
Summary:
This multicenter, prospective clinical trial is designed to enroll PD-L1
expression-positive patients with stage IB1 cervical cancer who desire fertility
preservation to undergo neoadjuvant chemotherapy in combination with a PD-1 inhibitor to
evaluate the rate of complete pathologic remission, treatment-related adverse events,
pregnancy rate, miscarriage rate, preterm birth rate, live birth rate, EFS and OS.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Clinical diagnosis of stage IB1 cervical cancer after gynecologic examination and
MRI evaluation by the investigator (FIGO 2018);
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:
1. History of infertility, including those with infertility due to tubal or (and)
husband;
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Huaiwu, PhD
Email:
luhuaiwu@163.com
Investigator:
Last name:
Huaiwu Lu, 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
Start date:
May 8, 2024
Completion date:
December 1, 2030
Lead sponsor:
Agency:
Tongji Hospital
Agency class:
Other
Collaborator:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Women Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Third Military Medical University
Agency class:
Other
Collaborator:
Agency:
Beijing Friendship Hospital
Agency class:
Other
Collaborator:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University
Agency class:
Other
Collaborator:
Agency:
West China Second University Hospital
Agency class:
Other
Collaborator:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
Gansu Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Shengjing Hospital
Agency class:
Other
Collaborator:
Agency:
Anhui Provincial Cancer Hospital
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/NCT06289062