Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer

NCT06289062 | Recruiting Phase 2 DMC

• 1 other identifier: NACI-CERV-005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Cervical Cancer; Neoadjuvant Chemoimmunotherapy; Fertility Preservation

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response

  Proportion of patients with no tumor cells on postoperative pathology and negative lymph node metastasis

  At the end of the patient's treatment, up to 2 years.

Secondary Outcomes (11)

• The negative conversion of HPV

  At the end of treatment, up to 2 years.

• Pregnancy rate

  Until the end of the 5-year follow-up period, up to 7 years.

• Miscarriage rate

  Until the end of the 5-year follow-up period, up to 7 years.

• Live birth rate

  Until the end of the 5-year follow-up period, up to 7 years.

• Preterm birth rate

  Until the end of the 5-year follow-up period, up to 7 years.

Study Arms (1)

NACI in FIGO ⅠB1 Cervical Cancer

EXPERIMENTAL

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.

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

Interventions

Camrelizumab DRUG

Camrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery

NACI in FIGO ⅠB1 Cervical Cancer

Cisplatin DRUG

75-80mg/m2, D1-D2，q3w (3 cycles)，intravenous infusion, administered at a rate of 1mg/min.

NACI in FIGO ⅠB1 Cervical Cancer

Nab paclitaxel DRUG

260 mg/m2，D1，q3w （3 cycles），intravenous infusion, administered over 30min.

NACI in FIGO ⅠB1 Cervical Cancer

biopsy PROCEDURE

cone biopsy + pelvic lymphadenectomy or Cervical biopsy + pelvic lymphadenectomy

NACI in FIGO ⅠB1 Cervical Cancer

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead
• 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

Study Sites (2)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

camrelizumab; Cisplatin; Taxes; Biopsy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Economics; Health Care Economics and Organizations; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ding Ma

  Tongji Hospital

  STUDY CHAIR

Central Study Contacts

Kezhen Li

CONTACT

086-027-8362; tjkeke@126.com

Jing Chen

CONTACT

086-027-8362; chenjing3223@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 1, 2024
• Study Start: May 8, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)