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Brief Title: Neoadjuvant Immunochemotherapy in PD-L1-negative LACC
Official Title: Neoadjuvant Chemotherapy Plus Camrelizumab in PD-L1-negative Locally Advanced Cervical Cancer: a Multicentre, Single-arm, Phase 2 Trial
Study ID: NCT06288360
Brief 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.
Detailed Description: This multicenter, prospective, single-arm clinical trial is designed to enroll patients with PD-L1-negative locally advanced cervical cancer with 1 course of priming neoadjuvant chemotherapy followed by 2 courses of neoadjuvant immunochemotherapy, to clarify the effects of neoadjuvant chemotherapy combined with a PD-1 inhibitor on tumor remission rate, surgical complications, and surgical cleanliness, and to evaluate the effects of neoadjuvant chemotherapy combined with a PD-1 inhibitor on the survival of patients with locally advanced cervical cancer, to clarify the effects of neoadjuvant chemotherapy combined with a PD-1 inhibitor on tumor remission rate, surgical complications, and complete resection rate, and to assess the effects of neoadjuvant chemotherapy combined with a PD-1 inhibitor on the survival of patients with locally advanced cervical cancer, and to explore the changes of local immune-related factors and tumor cells during the treatment process, as well as biomarkers that affect the efficacy of PD-1 combination therapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Name: Ding Ma
Affiliation: Tongji Hospital
Role: STUDY_CHAIR