Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-27 @ 8:54 AM
Study NCT ID:
NCT04767295
Status:
UNKNOWN
Last Update Posted:
2021-02-23
First Post:
2021-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Camrelizumab Combined With Chemotherapy as Neoadjuvant Therapy in Adcanced Esophageal Squamous Cell Carcinoma (ESCC)
Sponsor:
Hunan Cancer Hospital
Organization:
Study Overview
Official Title:
PD-1 Monoclonal Antibody Camrelizumab Combined With Albumin Paclitaxel and Platinum for Neoadjuvant Treatment of Adcanced Esophageal Squamous Cell Carcinoma (ESCC): A Single-center, Single-arm Phase II Clinical Study
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
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:
To evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and platinum chemotherapy in the preoperative treatment of locally advanced thoracic esophageal squamous cell carcinoma
Detailed Description:
Primary outcome:
1\. Analysis of prognosis efficacy of patients: pathologic complete response (pCR)
Secondary outcome:
Overall survival(OS), Progressive-free survival(PFS), Disease control rate(DCR), Objective response rate(ORR), and the proportion of subjects who completed all treatments and radical resection (R0);
Explorative outcome:
To explore the efficacy of ultrasound gastroscopy, PET/CT, peripheral circulating blood tumor cell (CTC) detection and CTC-based immunofluorescence detection of PD-L1 antibody for the treatment of locally advanced ESCC with camrelizumab combined with albumin paclitaxel and platinum and potential biomarkers for predicting the efficacy of camrelizumab, including but not limited to immunohistochemical detection of PD-L1 expression in tumor specimens, T cell receptor (TCR) sequencing analysis in peripheral blood, and esophageal microbiome Analysis, etc.; patients' quality of life
1\. Analysis of prognosis efficacy of patients: pathologic complete response (pCR)
Secondary outcome:
Overall survival(OS), Progressive-free survival(PFS), Disease control rate(DCR), Objective response rate(ORR), and the proportion of subjects who completed all treatments and radical resection (R0);
Explorative outcome:
To explore the efficacy of ultrasound gastroscopy, PET/CT, peripheral circulating blood tumor cell (CTC) detection and CTC-based immunofluorescence detection of PD-L1 antibody for the treatment of locally advanced ESCC with camrelizumab combined with albumin paclitaxel and platinum and potential biomarkers for predicting the efficacy of camrelizumab, including but not limited to immunohistochemical detection of PD-L1 expression in tumor specimens, T cell receptor (TCR) sequencing analysis in peripheral blood, and esophageal microbiome Analysis, etc.; patients' quality of life
Study Oversight
Has Oversight DMC:
False
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?: