Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
Study NCT ID:
NCT06666166
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-30
First Post:
2024-10-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer
Sponsor:
Yunpeng Liu
Organization:
Study Overview
Official Title:
Exploratory Clinical Study of SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
To evaluate the effectiveness and safety of SHR-A1811 combined with apatinib in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.
Detailed Description:
This is a prospective, dual arm, exploratory clinical research. To evaluate the effectiveness and safety of SHR-A1811 combined with apatinib in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.
Cohort A will enroll subjects with advanced gastric or gastroesophageal junction adenocarcinoma, while Cohort B will enroll subjects with advanced colorectal cancer.
The primary endpoint is objective remission rate (ORR). Secondary endpoints include disease control rate (DCR), duration of remission (DoR), progression-free survival (PFS), overall survival (OS) and safety.
Cohort A will enroll subjects with advanced gastric or gastroesophageal junction adenocarcinoma, while Cohort B will enroll subjects with advanced colorectal cancer.
The primary endpoint is objective remission rate (ORR). Secondary endpoints include disease control rate (DCR), duration of remission (DoR), progression-free survival (PFS), overall survival (OS) and safety.
Study Oversight
Has Oversight DMC:
True
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?: