Finding studies
Finding studies
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Zhenzhen Liu
CONTACT
Yajie Zhao
CONTACT
Lead
Henan Cancer Hospital
This study is a single center, non blinded, randomized phase II clinical trial. A total of 64 TNBC patients are planned to be enrolled. Patients who meet the inclusion criteria will be randomly divided into two groups (Group A and Group B) at a ratio of 1:1, and stratified according to T stage and N stage. The administration regimen is as follows: Group A: albumin-bound paclitaxe (260 mg/m²,d 1)+Carboplatin (AUC=5, d 1)+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles; Group B: albumin-bound paclitaxe (125 mg/m²,d 1,8,15)+Carboplatin (AUC=5, d 1 )+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles Primary endpoint: Pathological complete response rate (pCR rate). Secondary study endpoints: Objective response rate (ORR), event free survival rate (EFS), disease-free survival (DFS), distant disease free survival (DDFS), and safety. Exploratory endpoints: Differences in efficacy and immune microenvironment under different administration methods
Age
18–65
Sex
FEMALE
Healthy volunteers
Not accepted
