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RECRUITING
NCT06288373
PHASE2/PHASE3

Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

440

Start Date

2024-04-22

Completion Date

2031-03-01

Last Updated

2024-10-30

Healthy Volunteers

No

Interventions

DRUG

Camrelizumab

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

DRUG

Cisplatin

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

DRUG

Nab paclitaxel

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

PROCEDURE

Radical surgery

Radical surgery

RADIATION

external beam radiation therapy (EBRT) + brachytherapy

Radiation therapy per standard of care

DRUG

Cisplatin

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