Actively Recruiting
Neoadjuvant Chemotherapy Plus Camrelizumab (NACI Therapy) for Fertility Preservation in FIGO Stage IB1 Cervical Cancer
Led by Tongji Hospital · Updated on 2024-11-05
40
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for women with PD-L1 positive stage IB1 cervical cancer who want to preserve their fertility. This phase 2 clinical trial is designed to assess the effects of combining neoadjuvant chemotherapy with the PD-1 inhibitor camrelizumab. The study aims to measure complete pathologic remission, treatment side effects, pregnancy outcomes, and survival rates to better understand this therapy's impact on patients wishing to maintain fertility. Participants receive an initial cycle of platinum-based chemotherapy followed by two cycles combining camrelizumab and chemotherapy every three weeks. The study is conducted in two stages: in the first stage, patients with tumors 2 cm or smaller and no new lesions undergo cone biopsy and pelvic lymphadenectomy or sentinel lymph node mapping, with follow-up tests to decide further treatment. In the second stage, patients with similar tumor size undergo cervical biopsy and pelvic lymphadenectomy or sentinel lymph node mapping, followed by additional testing based on biopsy results. Treatments are given before surgery to evaluate effectiveness and fertility preservation. Throughout the study, participants are closely monitored with pathology tests, HPV testing, colposcopy, and patient-reported outcome questionnaires. Researchers will track pregnancy rates, miscarriage rates, preterm births, live births, adverse events, and surgical complications over treatment and follow-up periods up to seven years. Event-free and overall survival will also be measured. The total participation may last several years, allowing detailed evaluation of treatment effects and fertility outcomes.
CONDITIONS
Brief Title
Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of stage IB1 cervical cancer after gynecologic examination and MRI evaluation (FIGO 2018)
- Pathologically confirmed cervical squamous cell carcinoma
- Transformation zone of TZ1 or TZ2 (IFCPC 2011)
- Positive PD-L1 expression by preoperative pathology, Combined Positive Score (CPS) ≥1
- Female patients aged 18 to 45 years
- ECOG performance status score of 0 or 1
- Laboratory tests meeting minimum levels: WBC ≥3.5×10⁹/L, Neutrophils ≥1.5×10⁹/L, Platelets ≥100×10⁹/L
- Serum bilirubin and aminotransferase levels ≤1.5 times upper limit of normal
- Normal blood urea nitrogen (BUN) and creatinine levels
- Strong desire to preserve fertility and give birth
- Willingness to sign informed consent and comply with study requirements
You will not qualify if you...
- History of infertility, including tubal or husband-related infertility
- Any active or history of autoimmune disease requiring systemic treatment
- Prior treatment with immune checkpoint inhibitors or known hypersensitivity to study medication components
- History of HIV infection or active hepatitis B or C
- Use of immunosuppressive drugs or systemic corticosteroids (>10 mg/day prednisone or equivalent) within 2 weeks before study dosing
- History of primary malignancy or prior chemotherapy or pelvic radiation
- Concurrent participation in other clinical trials
- Pregnant or breastfeeding females; must agree to use effective contraception during and after treatment
- Uncontrolled co-morbidities including serious heart, vascular, neurological, hematologic, hepatic, or renal conditions
- Treatment with live or attenuated vaccines within 4 weeks prior to study drug dosing (except inactivated seasonal influenza vaccine)
- Previous allogeneic bone marrow or solid organ transplant
- Drug or alcohol abuse
- Unlikely to comply with study procedures, restrictions, and requirements as judged by investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks
Participants receive neoadjuvant chemotherapy with one cycle of platinum-based doublet priming chemotherapy followed by two cycles of camrelizumab combined with chemotherapy every 3 weeks before surgery.
3 treatment cycles every 3 weeks
Duration - 1 to 2 days
Participants undergo cone biopsy with pelvic lymphadenectomy or cervical biopsy with pelvic lymphadenectomy depending on tumor response and stage of enrollment.
1 surgical procedure visit
Duration - Up to 3 months
Participants are monitored with follow-up tests including TCT, HPV testing, and colposcopy depending on biopsy results and criteria to assess recovery and need for further treatment.
1 to 2 visits depending on biopsy results
Duration - Up to 5 years
Participants are followed for safety, pregnancy outcomes, and survival including assessments of adverse events, surgical complications, and patient-reported outcomes.
Periodic visits up to 5 years
Trial Site Locations
Total: 2 locations
1
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Actively Recruiting
2
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
K
Kezhen Li
J
Jing Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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