Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-25 @ 7:07 PM
Study NCT ID:
NCT06510660
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Sponsor:
Fujian Medical University Union Hospital
Organization:
Study Overview
Official Title:
Adebrelimab with or Without Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Prospective, Phase 2 Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
RICE
Brief Summary:
To evaluate the efficacy and safety of adebrelimab with or without induction chemotherapy followed by concurrent chemoradiotherapy for unresectable locally advanced esophageal squamous cell carcinoma
Detailed Description:
This is a prospective, two-cohort, multicenter clinical study. Subjects received different treatments based on their CPS scores. During induction therapy, subjects in cohort 1 (CPS score ≥10) received adebrelimab, while cohort 2 (CPS score \< 10) were administered adebrelizumab + carboplatin/cisplatin + paclitaxel/nab-paclitaxel. Both groups received carboplatin/cisplatin + paclitaxel/nab-paclitaxel combined radiotherapy during concurrent chemoradiotherapy. The primary endpoint was cCR rate.
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?: