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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• FIGO 2018 stage IB3, IIA2, or IIB/IIIC1r (tumor size\>4cm) cervical cancer and without any treatment (After undergoing gynecological examinations by two associate chief physicians or above, the staging of the patients was determined);

• Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. In principle, the size of the lesion as shown by the magnetic resonance imaging examination is used as the criterion.

• Histologically confirmed squamous carcinoma, adenocarcinoma (common type) or adenosquamous carcinoma of the cervix;

• Negative PD-L1 expression on preoperative pathological examination (Combined positive score \< 1);

• 18-70 years of age;

• Eastern Cooperative Oncology Group score ≤ 1;

• WBC≥3.5\*10\^9/L, NEU≥1.5\*10\^9/L, Platelet≥100×10\^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value;

• Well-compliance and willing to keep in touch;

• Willing to participate in this study, sign the informed consent, and comply with the requirements and limitations outlined in the Informed Consent Form (ICF) and this form.

Locations
Other Locations
China
Beiing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
Xiangya Hospital, Central South University
RECRUITING
Changsha
Second People's Hospital of Sichuan (Sichuan Cancer Hospital)
RECRUITING
Chengdu
The First Affiliated Hospital (Southwest Hospital), Army Medical University (Third Military Medical University)
RECRUITING
Chongqing
Women's Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
RECRUITING
Hangzhou
Anhui Provincial Cancer Hospital
RECRUITING
Hefei
Gansu Provincial Maternity and Child-care Hospital
RECRUITING
Lanzhou
The Affiliated Tumor Hospital of Guangxi Medical University
RECRUITING
Nanning
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Kezhen Li
tjkeke@126.com
086-027-8362
Backup
Jie Yang
yangjie@tjh.tjmu.edu.cn
086-027-8362
Time Frame
Start Date: 2024-09-12
Estimated Completion Date: 2030-12-12
Participants
Target number of participants: 40
Treatments
Experimental: Neoadjuvant chemotherapy plus camrelizumab (NACI)
Patients first received one cycle of platinum-based doublet priming chemotherapy. After 3 weeks, participants received two cycles of the PD-1 inhibitor camrelizumab combined with chemotherapy every 3 weeks. Patients with stable disease or progressive disease received concurrent chemoradiotherapy, and patients with a complete response or partial response proceeded to radical surgery.
Related Therapeutic Areas
Sponsors
Collaborators: Cancer Hospital of Guangxi Medical University, Xiangya Hospital of Central South University, Women's Hospital School Of Medicine Zhejiang University, West China Second University Hospital, Shengjing Hospital, Sichuan Cancer Hospital and Research Institute, Qilu Hospital of Shandong University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Beijing Friendship Hospital, Zhejiang Cancer Hospital, Gansu Provincial Maternal and Child Health Care Hospital, Tianjin Medical University General Hospital, Southwest Hospital, China, Anhui Provincial Cancer Hospital
Leads: Tongji Hospital

This content was sourced from clinicaltrials.gov