Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-29 @ 3:55 AM
Study NCT ID:
NCT05637268
Status:
UNKNOWN
Last Update Posted:
2022-12-05
First Post:
2022-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carrelizumab Combined With Chemotherapy for Adjuvant Therapy of Esophageal Squamous Cell Carcinoma
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Study Overview
Official Title:
Carrelizumab Combined With Chemotherapy for Adjuvant Therapy of Node-positive Thoracic Esophageal Squamous Cell Carcinoma: a One-arm, Phase II Clinical Study
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
RECRUITING
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-arm, open, exploratory clinical study to evaluate the efficacy and safety of camrelizumab combined with chemotherapy for adjuvant treatment of nodal positive thoracic esophageal squamous cell carcinoma.
Detailed Description:
Treatment with carrilizumab combined with chemotherapy was planned for 4 to 6 cycles, after which carrilizumab monotherapy was maintained until disease progression, unacceptable toxicity, or patient withdrawal.
vial card Rayleigh bead sheet resistance: intravenous drip, fixed dose of 200 mg, with 30 minutes to an intravenous drip
(The overall infusion time including the flushing time shall be no less than 20 minutes, no longer than 60 minutes), Day 1, every repeat once every 2 weeks.
paclitaxel: 150 mg/m2, intravenous drip for 30 minutes, 1 day, every 14 days for a cycle.
cisplatin: 50 mg/m2, 2 days, every 14 days for a cycle.
A total of 4 to 6 cycles, after carrilizumab maintenance treatment for one year.
vial card Rayleigh bead sheet resistance: intravenous drip, fixed dose of 200 mg, with 30 minutes to an intravenous drip
(The overall infusion time including the flushing time shall be no less than 20 minutes, no longer than 60 minutes), Day 1, every repeat once every 2 weeks.
paclitaxel: 150 mg/m2, intravenous drip for 30 minutes, 1 day, every 14 days for a cycle.
cisplatin: 50 mg/m2, 2 days, every 14 days for a cycle.
A total of 4 to 6 cycles, after carrilizumab maintenance treatment for one year.
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?: