RecruitingPhase 2NCT06289751

Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer

Neoadjuvant Chemotherapy Plus Cadunilizumab Followed by Extrafascial Hysterectomy for FIGO Stage IB2 Cervical Cancer: a Multicenter, Single-arm, Phase 2 Trial.


Sponsor

Tongji Hospital

Enrollment

50 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is an exploratory clinical trial to investigate the feasibility of neoadjuvant chemoimmunotherapy plus extrafascial hysterectomy and pelvic lymph node dissection in patients with stage IB2 (2018 FIGO) cervical cancer and to observe the response rate to treatment, adverse effects and complications, and to assess the survival rate of patients.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining chemotherapy and immunotherapy (a treatment that helps the immune system fight cancer) before surgery can be effective for women with early-stage cervical cancer (stage IB2). The goal is to shrink the tumor before performing a hysterectomy (surgical removal of the uterus). **You may be eligible if...** - You are 18–70 years old with untreated stage IB2 cervical cancer - Your cancer is confirmed as squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma - Your tumor tests positive for a protein called PD-L1 (CPS score of 1 or higher) - You have at least one measurable tumor on imaging - You are in good general health (ECOG score 0–1) with adequate blood, liver, and kidney function **You may NOT be eligible if...** - You have other types or stages of cervical cancer - Your tumor does not express PD-L1 - You have significant heart, liver, kidney, or blood problems - You have a history of autoimmune disease or prior immunotherapy 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

DRUGCadonilimab

10 mg/kg (body weight), 60 min, IV. Repeat every 3 weeks for a total of 3 cycles

DRUGPaclitaxel-albumin

260 mg/m2 for 30 min. Repeat every 3 weeks for a total of 3 cycles.

DRUGCisplatin

75-80 mg/m2, IV, 1 mg/min. Repeat every 3 weeks for a total of 3 cycles.

PROCEDUREExtrafascial hysterectomy

Extrafascial hysterectomy + pelvic lymphadenectomy (or SLN mapping) (For participants who meet ConCerv criteria)

PROCEDURERadical hysterectomy

Radical hysterectomy + pelvic lymphadenectomy ± para-aortic lymphadenectomy (or SLN mapping) (For participants who do not meet ConCerv criteria)

PROCEDURECone biopsy

Cold knife conization (CKC) (For participants with tumor size ≤2 cm after 3 cycles of chemo-immunotherapy)


Locations(2)

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

Wuhan, Hubei, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

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NCT06289751


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