Neoadjuvant Immunochemotherapy in PD-L1-negative LACC
NCT06288360 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-03-20
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.
Conditions
- Cervical Cancer
- Locally Advanced Cervical Cancer
- PD-L1 Negative
- Neoadjuvant Chemoimmunotherapy
Interventions
- DRUG
-
Camrelizumab
200 mg, intravenously, 20-60 min. 2 times, every 21 days
- DRUG
-
Paclitaxel-albumin
260 mg/m² over 30 min, 3 times, every 21 days
- DRUG
-
4 h, 75-80 mg/m², 3 times, every 21 days
- PROCEDURE
-
radical surgery
Radical hysterectomy + pelvic lymphadenectomy 士 para-aortic lymphadenectomy
Sponsors & Collaborators
-
Southwest Hospital, China
collaborator OTHER -
Women's Hospital School Of Medicine Zhejiang University
collaborator OTHER -
Anhui Provincial Cancer Hospital
collaborator OTHER -
Sichuan Cancer Hospital and Research Institute
collaborator OTHER -
Gansu Provincial Maternal and Child Health Care Hospital
collaborator OTHER -
Beijing Friendship Hospital
collaborator OTHER -
Tianjin Medical University General Hospital
collaborator OTHER -
Xiangya Hospital of Central South University
collaborator OTHER -
West China Second University Hospital
collaborator OTHER -
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
collaborator OTHER -
Zhejiang Cancer Hospital
collaborator OTHER -
Shengjing Hospital
collaborator OTHER -
Qilu Hospital of Shandong University
collaborator OTHER -
Cancer Hospital of Guangxi Medical University
collaborator OTHER -
Tongji Hospital
lead OTHER
Principal Investigators
-
Ding Ma · Tongji Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-12
- Primary Completion
- 2025-12-31
- Completion
- 2030-12-12
Countries
- China
Study Locations
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