Clinical trial NCT06289062: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cervical Cancer
Neoadjuvant Chemoimmunotherapy
Fertility Preservation
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Women's Hospital School Of Medicine Zhejiang University
name: Third Military Medical University
name: Beijing Friendship Hospital
name: Sichuan Cancer Hospital and Research Institute
name: Tianjin Medical University
name: West China Second University Hospital
name: Xiangya Hospital of Central South University
name: Qilu Hospital of Shandong University
name: Gansu Cancer Hospital
name: Zhejiang Cancer Hospital
name: Shengjing Hospital
name: Anhui Provincial Cancer Hospital
First posted: 2024-03-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Pathologic complete response
timeFrame: At the end of the patient's treatment, up to 2 years.
Secondary outcomes:
measure: The negative conversion of HPV
timeFrame: At the end of treatment, up to 2 years.
measure: Pregnancy rate
timeFrame: Until the end of the 5-year follow-up period, up to 7 years.
measure: Miscarriage rate
timeFrame: Until the end of the 5-year follow-up period, up to 7 years.
measure: Live birth rate
timeFrame: Until the end of the 5-year follow-up period, up to 7 years.
measure: Preterm birth rate
timeFrame: Until the end of the 5-year follow-up period, up to 7 years.
measure: Adverse Event
timeFrame: during the treatment, up to 5 years.
measure: Number of Participants with surgical complications
timeFrame: During and after the surgery, up to 2 years.
measure: Patient Reported Outcomes (EORTC QLQ-C30)
timeFrame: From enrollment to the end of the 5-year follow-up period. 5 years.
measure: Patient Reported Outcomes (EORTC QLQ-CX24)
timeFrame: From enrollment to the end of the 5-year follow-up period. 5 years.
measure: Event-free survival (EFS)
timeFrame: Until the end of the 5-year follow-up period, up to 7 years.
measure: Overall survival (OS)
timeFrame: Until the end of the 5-year follow-up period, up to 7 years.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Ding Ma
role: STUDY_CHAIR
References: