Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401447
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-05-02
Brief Title:
TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Medium Dose of Three Drugs TPF Concurrent Chemoradiotherapy Combined With PD-1 Checkpoint Inhibitor for Locally Advanced Esophageal Squamous Cell Carcinoma --Prospective Single Center Single Arm Phase II Clinical Study FUTURE-2
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The goal of this clinical trial is to learn if immune microenvironment modification could improve the effect of chemoradiotherapy for patients with local advanced esophageal squamous cell carcinoma The main questions it aims to answer are
1 Does immune microenvironment could be modified by medium dose of three drugs paclitaxel cisplatin 5-FU PD1 checkpoint inhibitor probiotics and thymosin α1
2 Does induction and consolidation of PD1 checkpoint inhibitor improve the effect of chemoradiotherapy for patients with esophageal cancer
This is a single arm study Participants will
1 Take one cycle of induction chemotherapy paclitaxel cisplatin 5-FU and immunotherapy Sintilimab two cycle of concurrent chemoradiotherapy one cycle of consolidation chemo-immunotherapy and then 1 year of immunotherapy
2 Take probiotics Clostridium Butyricum for 1 year and thymosin alpha-1 daily during radiotherapy
1 Does immune microenvironment could be modified by medium dose of three drugs paclitaxel cisplatin 5-FU PD1 checkpoint inhibitor probiotics and thymosin α1
2 Does induction and consolidation of PD1 checkpoint inhibitor improve the effect of chemoradiotherapy for patients with esophageal cancer
This is a single arm study Participants will
1 Take one cycle of induction chemotherapy paclitaxel cisplatin 5-FU and immunotherapy Sintilimab two cycle of concurrent chemoradiotherapy one cycle of consolidation chemo-immunotherapy and then 1 year of immunotherapy
2 Take probiotics Clostridium Butyricum for 1 year and thymosin alpha-1 daily during radiotherapy
Detailed Description:
Concurrent chemoradiotherapy is the standard treatment for patients with inoperable local advanced esophageal squamous cell carcinoma However over half of patients will relapse How to improve effects We focus on tumor microenvironment transformation by three drug chemotherapy PD1 inhibitor probiotics and thymosin α1and intent to improve radiosensitivity and reduce recurrence
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