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RecruitingPhase 2NCT06288360

Neoadjuvant Immunochemotherapy in PD-L1-negative LACC

Neoadjuvant Chemotherapy Plus Camrelizumab in PD-L1-negative Locally Advanced Cervical Cancer: a Multicentre, Single-arm, Phase 2 Trial

Sponsor

Tongji Hospital

Enrollment

40 participants

Start Date

Sep 12, 2024

Study Type

INTERVENTIONAL

Conditions

Cervical CancerNeoadjuvant ChemoimmunotherapyLocally Advanced Cervical CancerPD-L1 Negative

Summary

This is a multicenter, prospective, single-arm, phase 2 clinical trial designed to evaluate the therapeutic efficacy of the NACI (neoadjuvant chemotherapy plus Camrelizumab) for PD-L1-negative locally advanced cervical cancer.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding immunotherapy (a checkpoint inhibitor) to standard chemotherapy before surgery improves outcomes in patients with locally advanced cervical cancer whose tumors do not express the PD-L1 protein. **You may be eligible if...** - You have locally advanced cervical cancer (stage IB3, IIA2, IIB, or IIIC1r with a tumor larger than 4 cm) with no prior treatment - Your cancer is confirmed to be squamous cell, adenocarcinoma (common type), or adenosquamous carcinoma - Your tumor's PD-L1 test came back NEGATIVE (combined positive score less than 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 positive - You have had any prior cancer treatment - Your blood counts, liver, or kidney function do not meet the minimum requirements 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

200 mg, intravenously, 20-60 min. 2 times, every 21 days

DRUGPaclitaxel-albumin

260 mg/m² over 30 min, 3 times, every 21 days

DRUGCisplatin

4 h, 75-80 mg/m², 3 times, every 21 days

PROCEDUREradical surgery

Radical hysterectomy + pelvic lymphadenectomy 士 para-aortic lymphadenectomy

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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NCT06288360

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