Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-19 @ 5:17 AM
Study NCT ID:
NCT06588335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BTLA Inhibitor (JS004) Combined with Toripalimab and Chemotherapy in the Perioperative Treatment of Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Sponsor:
Henan Provincial People's Hospital
Organization:
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:
False
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:
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?:
False
Is an FDA AA801 Violation?: