RecruitingPhase 2NCT06289062

Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer

Neoadjuvant Chemotherapy Plus Camrelizumab (NACI Therapy) for Fertility Preservation in FIGO Stage IB1 Cervical Cancer


Sponsor

Tongji Hospital

Enrollment

40 participants

Start Date

May 8, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding camrelizumab (an immunotherapy drug) to chemotherapy before surgery can improve outcomes for young women with early-stage cervical cancer (stage IB1) who want to preserve their fertility. **You may be eligible if...** - You have been diagnosed with stage IB1 cervical squamous cell carcinoma (confirmed by biopsy) - Your tumor's PD-L1 test is POSITIVE (combined positive score ≥ 1) - You are between 18 and 45 years old and have a strong desire to have children in the future - You are in good general health (ECOG ≤ 1) and your blood counts and organ function meet minimum requirements **You may NOT be eligible if...** - Your cervical cancer is a different histological type (not squamous cell carcinoma) - Your tumor is PD-L1 negative - You do not wish to preserve fertility - You have poor organ function or blood count issues Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCamrelizumab

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

DRUGCisplatin

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

DRUGNab paclitaxel

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

PROCEDUREbiopsy

cone biopsy + pelvic lymphadenectomy or Cervical biopsy + pelvic lymphadenectomy


Locations(2)

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

Guangzhou, Guangdong, China

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

Wuhan, Hubei, China

View Full Details on ClinicalTrials.gov

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NCT06289062


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