Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310473
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-20
Brief Title:
Neoadjuvant Cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer Trial
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital Southern Medical University
Study Overview
Official Title:
Efficacy and Safety of Neoadjuvant Cadonilimab and Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer a Prospective Open-label Single-Arm Phase II Study
Status:
NOT_YET_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:
None
Brief Summary:
For locally advanced esophagogastric junction and gastric cancer neoadjuvant chemotherapy can downstage T and N stagetreated distant micrometastases early and finally improve the long-term survival Combination of perioperative PD-1 antibody and chemotherapy for locally advanced esophagogastric junction and gastric cancer could be a novel therapy to increase response rate and reduce recurrence rateCadonilimab a tetravalent bispecific antibody targeting PD-1 and CTLA-4 is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy The aim of this study is to evaluate the efficacy and safety of cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer
Detailed Description:
Locally advanced esophagogastric junction and gastric cancer could be cured by multi-disciplinary therapies including surgery chemotherapy and radiotherapy Neoadjuvant chemotherapy can downstage T and N stage treated distant micrometastases early before local therapy has begun and finally improve the long-term survival However the therapeutic effects remain unsatisfactoryCadonilimab AK104 a novel bispecific antibody simultaneously targeting PD-1 and CTLA-4 was designed to boost anti-tumor activity with a favorable safety profileThis study was a single arm open-label clinical study to evaluate the efficacy and safety of combination with Cadonilimab and Chemotherapy for neoadjuvant treatment of resectable locally advanced adenocarcinoma of the gastro-esophageal junction
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