Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588335
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
BTLA Inhibitor JS004 Combined with Toripalimab and Chemotherapy in the Perioperative Treatment of Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-Center Exploratory Study of BTLA Inhibitor JS004 Combined with Toripalimab and Chemotherapy in the Perioperative Treatment of Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center single-arm phase II study aiming to preliminarily explore the efficacy and safety of JS004 combined with toripalimab and chemotherapy for perioperative treatment of locally advanced thoracic esophageal squamous cell carcinoma that is resectable The plan is to enroll 20 patients with locally advanced resectable thoracic esophageal cancer In the neoadjuvant treatment phase patients will receive JS004 toripalimab chemotherapy paclitaxel cisplatin for 2 cycles This will be followed by the surgical phase surgery will be performed 3-8 weeks after the last dose of neoadjuvant treatment In the postoperative maintenance treatment phase maintenance treatment will start 4 weeks 7 days after surgery but no later than 10 weeks after surgery For patients with R0 resection confirmed by postoperative pathology they will receive maintenance treatment with JS004 toripalimab for up to 15 cycles For patients with non-R0 resection they will receive maintenance treatment with JS004 toripalimab combined with standard radiation or chemotherapy selected by the investigator based on esophageal cancer guidelines During the study the maximum number of cycles of JS004 combined with toripalimab is 17 cycles approximately 1 year
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None