Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT06718205
Status:
RECRUITING
Last Update Posted:
2024-12-05
First Post:
2024-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nimotuzumab Combined With Sintilimab and Chemotherapy for Advanced Esophageal Squamous Cell Carcinoma
Sponsor:
The First Affiliated Hospital of Zhengzhou University
Organization:
Study Overview
Official Title:
Open-label, Single-arm, Multicenter Phase II Study of Nimotuzumab Injection Combined With Sintilimab and Chemotherapy as First-line Treatment for Advanced Esophageal Squamous Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-12
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 study is a prospective, single-arm, multicenter study. The patients were given chemotherapy with nimotuzumab and sindilimab. To analyze the efficacy and safety of nimotuzumab combined with sindilizumab and chemotherapy in first-line treatment of advanced or recurrent or metastatic esophageal cancer.
Detailed Description:
This study is a prospective, single-arm, multicenter study. Patients with locally advanced, metastatic esophageal squamous cell carcinoma who had received previous (new adjuvant) / radical treatment (including radical surgical resection and radical chemoradiotherapy) who had relapsed more than 6 months and did not receive other antitumor treatment The patients were given 4-6 cycles of chemotherapy with nimotuzumab and sindilimab and TP (according to the degree of tolerance), and continued maintenance therapy with nimotuzumab and sindilimab. Medication continued until disease progression or the patient was intolerable or the patient died or withdrawal from the study, nimotuzumab and sindilimab for 2 years and follow-up observation for 1 year. To analyze the efficacy and safety of nytuzumab combined with cindilizumab and chemotherapy in first-line treatment of advanced or recurrent or metastatic esophageal cancer.
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?: