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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

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