Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143748
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-11-15
Brief Title:
Combination of Cadonilimab and Chemoradiotherapy in Esophageal Cancer EC-CRT-006
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Cadonilimab Combined With Induction Chemotherapy and Definitive Radiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma a Phase II Single-arm Trial EC-CRT-006
Status:
RECRUITING
Status Verified Date:
2024-03
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:
EC-CRT-006
Brief Summary:
Definitive chemoradiotherapy CRT is the standard treatment option for unresectable locally advanced esophageal cancer However as high as more than 40 of patients with esophageal cancer experienced locoregional recurrence after definitive CRT Immune checkpoint inhibitors targeting PD-1PD-L1 andor CTLA-4 have shown substantial clinical benefits in advanced esophageal cancer Recently the combination of immunotherapy with CRT has emerged as a promising strategy to improve clinical outcomes in esophageal cancer The aim of this study was to evaluate the efficacy and safety of cadonilimab a bispecific PD-1CTLA-4 antibody combined with induction chemotherapy followed by definitive radiotherapy in patients with locally advanced esophageal squamous cell carcinoma
Detailed Description:
A total of 46 patients with unresectable locally advanced ESCC will be enrolled to receive cadonilimab plus induction chemotherapy followed by definitive radiotherapy and then 12 additional cycles of maintenance therapy with cadonilimab
Patients will receive 2 cycles of 3-weekly schedule of induction chemotherapy consisting of paclitaxel 135 mgm2 cisplatin 75 mgm2 and cadonilimab 10 mgkg on day 1 prior to CRT Then all patients will receive standard fractionation radiation therapy scheme 504 Gy in 28 fractions concurrently with 2 cycles of cadonilimab After the completion of radiotherapy patients will then receive 12 additional cycles of cadonilimab
Patients will receive 2 cycles of 3-weekly schedule of induction chemotherapy consisting of paclitaxel 135 mgm2 cisplatin 75 mgm2 and cadonilimab 10 mgkg on day 1 prior to CRT Then all patients will receive standard fractionation radiation therapy scheme 504 Gy in 28 fractions concurrently with 2 cycles of cadonilimab After the completion of radiotherapy patients will then receive 12 additional cycles of cadonilimab
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?:
None