Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer

Tongji Hospital

Status and phase: Enrolling; Phase 2

Conditions: Neoadjuvant Chemoimmunotherapy; Fertility Preservation; Cervical Cancer

Treatments: Procedure: biopsy; Drug: Camrelizumab; Drug: Cisplatin; Drug: Nab paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT06289062

NACI-CERV-005

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

NACI in FIGO ⅠB1 Cervical Cancer

Experimental group

Description:

Neoadjuvant chemotherapy plus camrelizumab for ⅠB1 Cervical Cancer. Patients first received one cycle of platinum-based doublet priming chemotherapy. After 3 weeks, participants subsequently received two cycles of the PD-1 inhibitor camrelizumab combined with chemotherapy every 3 weeks. The study will be conducted in two stages: (1) Patients enrolled in the first stage with tumors ≤2 cm and no new lesions after completion of treatment will undergo cone biopsy + pelvic lymphadenectomy or SLN mapping. Those who meet ConCerv criteria will undergo a second TCT, human papillomavirus (HPV) and colposcope 3 months later, and those who do not meet ConCerV criteria will undergo radical cervical surgery. (2) Patients enrolled in the second stage with tumors ≤2 cm and no new lesions underwent cervical biopsy + pelvic lymphadenectomy or SLN mapping; patients with LSIL on biopsy underwent TCT, HPV, and colposcope 3 months later; if biopsy suggests HSIL and above, perform cone biopsy.

Treatment:

Drug: Nab paclitaxel

Drug: Cisplatin

Drug: Camrelizumab

Procedure: biopsy