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Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC
Sponsor: Tongji Hospital
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
Conditions
Interventions
Camrelizumab
Camrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery
Cisplatin
Cisplatin:75-80mg/m2, D1-D2,q3w (3 cycles),intravenous infusion, administered at a rate of 1mg/min.
Nab paclitaxel
Nab paclitaxel: 260 mg/m2,D1,q3w (3 cycles),intravenous infusion, administered over 30min.
Radical surgery
Radical surgery
external beam radiation therapy (EBRT) + brachytherapy
Radiation therapy per standard of care
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