Actively Recruiting
Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer
Led by Tongji Hospital · Updated on 2024-11-05
40
Participants Needed
2
Research Sites
342 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
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
Official 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 confirmed by gynecologic exam and MRI (FIGO 2018)
- Pathologically confirmed cervical squamous cell carcinoma
- Transformation zone of TZ1 or TZ2 (IFCPC 2011)
- Positive PD-L1 expression with Combined Positive Score (CPS) 21
- Age between 18 and 45 years
- ECOG performance status of 0 or 1
- Laboratory tests showing WBC 2 3.5�D7109/L, neutrophils 2 1.5�D7109/L, platelets 2 100�D7109/L, bilirubin and aminotransferase levels 2 1.5 times upper limit of normal, and normal blood urea nitrogen and creatinine
- Strong desire to have children
- Willingness to sign informed consent and comply with study requirements
You will not qualify if you...
- History of infertility, including tubal or partner-related infertility
- Active or history of autoimmune diseases requiring systemic treatment
- Previous treatment with immune checkpoint inhibitors or hypersensitivity to study drugs
- 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
- History of other primary cancers or prior chemotherapy or pelvic radiation
- Participation in other clinical trials
- Pregnant or breastfeeding; must agree to use effective contraception during and after study
- Uncontrolled heart, vascular, brain, hematologic, liver, or kidney conditions
- Active infections requiring systemic treatment within 14 days before first dose
- Live or attenuated vaccine use within 4 weeks before first dose (except inactivated influenza vaccine)
- Prior allogeneic bone marrow or organ transplant
- Drug or alcohol abuse
- Unable to comply with study procedures or requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
J
Jing Chen
CONTACT
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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