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RecruitingPhase 2Phase 3NCT06288373

Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC

Neoadjuvant Chemoimmunotherapy Combined With Surgery Versus Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer: a Multicenter Randomized Controlled Clinical Trial

Sponsor

Tongji Hospital

Enrollment

440 participants

Start Date

Apr 22, 2024

Study Type

INTERVENTIONAL

Conditions

Cervical CancerConcurrent ChemoradiotherapyNeoadjuvant ChemoimmunotherapyLocally Advanced Cervical Cancer

Summary

It is a prospective, open-label, randomized, controlled phase II/III clinical trial in which patients with PD-L1-positive FIGO stage IB3, IIA2 and IIB（tumors \>4 cm in diameter）will be enrolled and randomly divided into the neoadjuvant chemoimmunotherapy plus surgery group and the CCRT group.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment approaches for locally advanced cervical cancer in patients whose tumors are PD-L1 positive: chemotherapy plus immunotherapy before surgery versus standard radiation combined with chemotherapy. **You may be eligible if...** - You have locally advanced cervical cancer (stage IB3, IIA2, or IIB with tumor larger than 4 cm) that has not been previously treated - Your cancer is squamous cell, adenocarcinoma (common type), or adenosquamous carcinoma - Your tumor's PD-L1 test is POSITIVE (combined positive score ≥ 1) - You are between 18 and 70 years old and in good general health (ECOG ≤ 1) **You may NOT be eligible if...** - Your tumor is PD-L1 negative - You have had any prior treatment for cervical cancer - Your blood counts, liver, or kidney function do not meet the minimum thresholds 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

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

DRUGNab paclitaxel

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

PROCEDURERadical surgery

Radical surgery

RADIATIONexternal beam radiation therapy (EBRT) + brachytherapy

Radiation therapy per standard of care

DRUGCisplatin

Chemotherapy administered concurrent with radiation therapy，cisplatin 40 mg/m2 IV once per week (QW) for 5 weeks

Locations(12)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Beiing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hospital (Southwest Hospital), Army Medical University (Third Military Medical University)

Chongqing, Chongqing Municipality, China

Gansu Provincial Maternity and Child-care Hospital

Lanzhou, Gansu, China

The Affiliated Tumor Hospital of Guangxi Medical University

Nanning, Guangxi, China

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

Wuhan, Hubei, China

Xiangya Hospital, Central South University

Changsha, Hunan, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Second People's Hospital of Sichuan (Sichuan Cancer Hospital)

Chengdu, Sichuan, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Women's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences

Hangzhou, Zhejiang, China

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NCT06288373

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