Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer

Official title

Neoadjuvant Chemotherapy Plus Camrelizumab (NACI Therapy) for Fertility Preservation in FIGO Stage IB1 Cervical Cancer

Overview

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.

Interventions

• Drug Camrelizumab
  Camrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery
• Drug Cisplatin
  75-80mg/m2, D1-D2，q3w (3 cycles)，intravenous infusion, administered at a rate of 1mg/min.
• Drug Nab paclitaxel
  260 mg/m2，D1，q3w （3 cycles），intravenous infusion, administered over 30min.
• Procedure biopsy
  cone biopsy + pelvic lymphadenectomy or Cervical biopsy + pelvic lymphadenectomy

Primary outcome measures

• Pathologic complete response [Time frame: At the end of the patient's treatment, up to 2 years.]

Secondary outcome measures (11)

• The negative conversion of HPV [Time frame: At the end of treatment, up to 2 years.]
• Pregnancy rate [Time frame: Until the end of the 5-year follow-up period, up to 7 years.]
• Miscarriage rate [Time frame: Until the end of the 5-year follow-up period, up to 7 years.]
• Live birth rate [Time frame: Until the end of the 5-year follow-up period, up to 7 years.]
• Preterm birth rate [Time frame: Until the end of the 5-year follow-up period, up to 7 years.]
• Adverse Event [Time frame: during the treatment, up to 5 years.]
• Number of Participants with surgical complications [Time frame: During and after the surgery, up to 2 years.]
• Patient Reported Outcomes (EORTC QLQ-C30) [Time frame: From enrollment to the end of the 5-year follow-up period. 5 years.]
• Patient Reported Outcomes (EORTC QLQ-CX24) [Time frame: From enrollment to the end of the 5-year follow-up period. 5 years.]
• Event-free survival (EFS) [Time frame: Until the end of the 5-year follow-up period, up to 7 years.]
• Overall survival (OS) [Time frame: Until the end of the 5-year follow-up period, up to 7 years.]

Eligibility criteria

Inclusion criteria

• Clinical diagnosis of stage IB1 cervical cancer after gynecologic examination and MRI evaluation by the investigator (FIGO 2018);
• Pathologically confirmed diagnosis of cervical squamous cell carcinoma;
• Transformation zone of TZ1 or TZ2 (IFCPC 2011);
• Positive PD-L1 expression by preoperative pathology, i.e., Combined Positive Score (CPS) ≥1;
• Patient age ≥18 years and ≤45 years;
• ECOG score ≤1;
• 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;
• Have a strong desire to give birth;
• Willing to sign the informed consent form, including compliance with the requirements and restrictions listed in the informed consent form and program.

Exclusion criteria

• History of infertility, including those with infertility due to tubal or (and) husband;
• 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;
• 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;
• History of human immunodeficiency virus (HIV) infection or known active hepatitis B or C;
• Use of immunosuppressive drugs or systemic corticosteroid therapy for immunosuppression (>10 mg/day prednisone or equivalent) within 2 weeks prior to study dosing;
• History of primary malignancy or receipt of chemotherapy or pelvic radiation;
• Concurrent participation in other clinical trials;
• 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;
• 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;
• Treatment with live or attenuated vaccine within 4 weeks prior to the first dose of study drug; inactivated seasonal influenza virus vaccine is permitted;
• Patients who have received a previous allogeneic bone marrow or solid organ transplant;
• Drug and/or alcohol abuse;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 2 centers

• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan

Publications

• Hu Y, Chen S, Cheng H, Han Y, Sun C, Chen G, Chen J, Li K. Chemotherapy plus camrelizumab for fertility preservation (NACI-F) in FIGO stage IB1 cervical cancer: a multicenter, single-arm, phase 2 trial. J Gynecol Oncol. 2026 Apr 29. doi: 10.3802/jgo.2026.37.e98. Online ahead of print. PMID 42172490

Identifiers

NCT: NCT06289062 · NACI-CERV-005

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗