Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorTongji Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Camrelizumab
DrugCamrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery
Cisplatin
Drug75-80mg/m2, D1-D2，q3w (3 cycles)，intravenous infusion, administered at a rate of 1mg/min.
Nab paclitaxel
Drug260 mg/m2，D1，q3w （3 cycles），intravenous infusion, administered over 30min.
biopsy
Procedure/Surgerycone biopsy + pelvic lymphadenectomy or Cervical biopsy + pelvic lymphadenectomy
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: NACI in FIGO ⅠB1 Cervical CancerExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Pathologic complete response
Proportion of patients with no tumor cells on postoperative pathology and negative lymph node metastasis
Time frame
At the end of the patient's treatment, up to 2 years.Secondary outcomes
1
The negative conversion of HPV
Proportion of patients with known HPV infection at screening who are HPV-negative after treatment
Time frame
At the end of treatment, up to 2 years.2
Pregnancy rate
the ratio of the number of women with a successful pregnancy to the total number of women who attempted to become pregnant
Time frame
Until the end of the 5-year follow-up period, up to 7 years.3
Miscarriage rate
the ratio of miscarriage events that occur during pregnancy in women who are pregnant
Time frame
Until the end of the 5-year follow-up period, up to 7 years.4
Live birth rate
The live birth rate is the ratio of the number of babies successfully delivered and surviving to the total number of women who attempted pregnancy
Time frame
Until the end of the 5-year follow-up period, up to 7 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tongji Hospital
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Women's Hospital School Of Medicine Zhejiang University
Collaborator
Third Military Medical University
Collaborator
Beijing Friendship Hospital
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Tianjin Medical University
Collaborator
West China Second University Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
Qilu Hospital of Shandong University
Collaborator
Gansu Cancer Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
Shengjing Hospital
Collaborator
Anhui Provincial Cancer Hospital
Collaborator
Source ClinicalTrials.gov