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New treatment option for Cervical Cancer
Official title Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer
ClinicalTrials.gov ID: NCT06289062
What this study is testing
What is Camrelizumab?
Camrelizumab is an investigational medicine, being studied as a potential treatment for cervical cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join 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;
You likely can't join 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...
- Prior treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; known hypersensitivity to...
- 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...
- History of primary malignancy or receipt of chemotherapy or pelvic radiation;
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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; people 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.