This is a phase II, open-label, single-arm, multicenter study of the efficacy and safety of atezolizumab treatment in participants with advanced thymic carcinoma who failed prior systemic therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Atezolizumab 1200 mg will be administered by IV on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.
Sichuan Cancer Hospital
Chengdu, China
West China Hospital, Sichuan University; Department of Breast
Chengdu, China
The Second Affiliated Hospital, Chongqing Medical University
Chongqing, China
Objective response rate (ORR)
ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions 4 weeks apart, as determined by the Investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Time frame: Baseline up to approximately 3.5 years
Progression-Free Survival (PFS)
PFS is defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.
Time frame: Baseline up to approximately 3.5 years
Overall Survival (OS)
OS is defined as the time from initiation of study treatment to death from any cause.
Time frame: Baseline up to approximately 3.5 years
Duration of Objective Response (DOR)
DOR is defined as the time from initial response to disease progression or death among patients who have experienced a CR or PR (unconfirmed) during the study. Duration of response will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.
Time frame: Baseline up to approximately 3.5 years
Disease Control Rate (DCR)
DCR is defined as the proportion of patients who have a best overall response of CR or PR or SD, as determined by the investigator according to RECIST v1.1
Time frame: Baseline up to approximately 3.5 years
Distribution of TMB Expression
Positive is defined as \>=10 Muts/Mb. Negative is defined as \<10 Muts/Mb.
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Fujian Medical University Union Hospital
Fuzhou, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, China
The affiliated hospital of Qingdao university
Qingdao, China
Shanghai Chest Hospital
Shanghai, China
Tianjin Cancer Hospital
Tianjin, China
Henan Cancer Hospital
Zhengzhou, China
Time frame: Baseline up to approximately 3.5 years
Distribution of PD-L1 Expression
Positive is defined as TC or IC \>=1%. Negative is defined as TC or IC \<1%.
Time frame: Baseline up to approximately 3.5 years
Percentage of Participants With Adverse Events
Time frame: Baseline up to approximately 3.5 years
Percentage of Participants With Immune-Related Adverse Events
Time frame: Baseline up to approximately 3.5 years