Ignite Creation Date:
2024-05-06 @ 2:52 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04459078
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-12-02
First Post:
2020-06-29
Brief Title:
Clinical Study of Camrelizumab Combined With APatinib and Albumin Paclitacxel in Patients With Advanced Lung Adenocarcinoma
Sponsor:
Hunan Cancer Hospital
Organization:
Hunan Cancer Hospital
Study Overview
Official Title:
A Prospective Single-arm Phase II Clinical Study to Evaluate the Efficacy of Camrelizumab in Combined With APatinib and Albumin Paclitacxel in Advanced Untreated EGFR Wild Type and ALK-negative Lung Adenocarcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a single arm open label national multicenter study to explore the efficacy and safety of the combination of Camrelizumab apatinib and albumin paclitaxel in advanced untreated EGFR Wild Type and ALK-negative Lung Adenocarcinoma The study does not consider PD-L1 expression but tumor samples need to be explored by PD-L1 detection and other exploratory analysis
Detailed Description:
Primary outcome
1 progression free survival PFS evaluated according to RECIST11
Secondary outcome
1 Objective Response Rate ORR Overall Survival OS Disease Control Rate DCR Duration of Response DOR evaluated according to RECIST11 and Quality of LifeQOL
2 The overall incidence of adverse events AE the incidence of grade 3 or above AE the incidence of serious adverse events SAE the incidence of AE leading to the termination of the trial drug the incidence of AE leading to the suspension of the trial drug
3 Exploratory analysis of potential biomarkers related to efficacy The characteristics of tumor tissue PD-L1expression panel-captured next generation sequencingNGS RNA-seq T-Cell Repertoire TCR multiple immunofluorescence and other biomarkers and the correlation analysis of biomarkers with efficacy and safety
1 progression free survival PFS evaluated according to RECIST11
Secondary outcome
1 Objective Response Rate ORR Overall Survival OS Disease Control Rate DCR Duration of Response DOR evaluated according to RECIST11 and Quality of LifeQOL
2 The overall incidence of adverse events AE the incidence of grade 3 or above AE the incidence of serious adverse events SAE the incidence of AE leading to the termination of the trial drug the incidence of AE leading to the suspension of the trial drug
3 Exploratory analysis of potential biomarkers related to efficacy The characteristics of tumor tissue PD-L1expression panel-captured next generation sequencingNGS RNA-seq T-Cell Repertoire TCR multiple immunofluorescence and other biomarkers and the correlation analysis of biomarkers with efficacy and safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None