Neoadjuvant chemotherapy with Camrelizumab for early-stage cervical cancer
Official title: Neoadjuvant Chemotherapy Plus Camrelizumab (NACI Therapy) for Fertility Preservation in FIGO Stage IB1 Cervical Cancer
Run by Tongji Hospital · NCT06289062 · Data updated 2026-11-12
This study is testing if a new combination of chemotherapy and a drug called Camrelizumab can help women with early-stage cervical cancer keep their fertility while aiming for complete remission.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Status | Recruiting |
| Started | May 8, 2024 |
| Main results expected | December 1, 2025 |
| Study ends | December 1, 2030 |
| Registry record updated | November 5, 2024 |
| Trial ID | NCT06289062 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 to 45 with stage IB1 cervical squamous cell carcinoma and positive PD-L1 expression who wish to maintain their fertility.
✕Probably not a fit
Patients with a history of infertility or those not expressing PD-L1 may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, prospective clinical trial aims to enroll patients with FIGO stage IB1 cervical cancer who express PD-L1 and wish to preserve their fertility. Participants will receive neoadjuvant chemotherapy combined with the PD-1 inhibitor Camrelizumab to assess the effectiveness in achieving complete pathologic remission, as well as monitoring treatment-related adverse events and pregnancy outcomes. The study will evaluate various metrics including live birth rates and overall survival.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and fertility preservation for patients with early-stage cervical cancer.
How similar studies have gone: Other studies have shown promise in combining chemotherapy with immunotherapy for cancer treatment, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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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, China Recruiting
Study contacts
- Study coordinator: Kezhen Li
- Email: tjkeke@126.com
- Phone: 086-027-8362
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Neoadjuvant chemoimmunotherapy and surgery for early-stage cervical cancer
This study is testing if a new treatment combining chemotherapy and immunotherapy before surgery can help women with early-stage cervical cancer do better and have fewer complications.
-
Comparing neoadjuvant chemoimmunotherapy and concurrent chemoradiotherapy for locally advanced cervical cancer
This study is testing whether a new treatment combining chemoimmunotherapy and surgery can help people with locally advanced cervical cancer do better than the standard treatment of chemo and radiation.
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Neoadjuvant immunochemotherapy for PD-L1-negative locally advanced cervical cancer
This study is testing a new treatment that combines chemotherapy with a drug called Camrelizumab to see if it can help people with PD-L1-negative locally advanced cervical cancer before surgery.
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This study tests different ways to screen and manage high-risk HPV in women with HIV to see what might work best for them.
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Hydrogel spacer to protect the rectum during cervical cancer radiotherapy
This study tests whether placing an absorbable hydrogel spacer between the cervix/vagina and rectum before definitive radiotherapy can reduce rectal radiation exposure for women with cervical cancer.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.