Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04644250
Status:
UNKNOWN
Last Update Posted:
2020-11-25
First Post:
2020-11-16
Brief Title:
Combination of Toripalimab and Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
Sponsor:
Wei Ren
Organization:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Overview
Official Title:
Phase II of Toripalimab Chemoradiotherapy in Neoadjuvant Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma A Single-centerOpen LableSingle-arm Exploratory Clinical Research
Status:
UNKNOWN
Status Verified Date:
2020-11
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:
Radical resection is thought to be the mainstay of esophageal cancer treatment Neoadjuvant chemoradiotherapy CRT followed by surgery has become the standard treatment option for locally advanced esophageal squamous cell cancer ESCC However only 20 to 40 of patients can achieve pathologic complete response pCR after neoadjuvant CRT with favorable prognosis and about 10 of patients have disease progression after chemoradiotherapy How to improve the the efficacy of neoadjuvant therapy is an important clinical problem to be solved
Immunotherapy targeting the programmed cell death receptor-1PD-1 programmed cell death-Ligand 1PD-L1 checkpoints has demonstrated promising activity in ESCC In Keynote181 study for patients with metastatic esophageal squamous cell carcinoma regardless of PD-L1 expression pembrolizumab significantly improved overall survival compared with chemotherapy However the efficacy and safety of immunotherapy therapy in surgery-based multidisciplinary treatment of local advanced esophageal cancer still need a lot of clinical studies to further confirm
This study aims to investigate the safety and efficacy of Toripalimab combined with radiotherapy and chemotherapy in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma
Immunotherapy targeting the programmed cell death receptor-1PD-1 programmed cell death-Ligand 1PD-L1 checkpoints has demonstrated promising activity in ESCC In Keynote181 study for patients with metastatic esophageal squamous cell carcinoma regardless of PD-L1 expression pembrolizumab significantly improved overall survival compared with chemotherapy However the efficacy and safety of immunotherapy therapy in surgery-based multidisciplinary treatment of local advanced esophageal cancer still need a lot of clinical studies to further confirm
This study aims to investigate the safety and efficacy of Toripalimab combined with radiotherapy and chemotherapy in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma
Detailed Description:
This study was designed as an open-lable single-arm single-centerexploratory clinical study Toripalimab combination of chemoradiotherapy as neoadjuvant therapy Participants will receive carboplatin AUC2 and paclitaxel liposome 50mgm² on day 310172431 And radiotherapy Intensity-modulated radiation therapyIMRTwill start from day 1 to 31 of chemotherapy A total of 414 Gy 23 fractions of 18 Gy Participants will also receive Toripalimab 240mg on days 3 24and 45 After the neoadjuvant treatment is over the short-term efficacy evaluation will be performed first and then a radical resection will be scheduled on Day 59 to 73 This study include 2 phases 14 cases were enrolled in the first stage and 18 cases were enrolled in the second stage
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