Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06385873
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-24
Brief Title:
RC48 Combined With Adebrelimab Apatinib and S-1 as Neoadjuvant Therapy in Locally Advanced Gastric Cancer
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
Disitamab Vedotin Combined With Adebrelimab Apatinib and S-1 as Neoadjuvant Therapy in Locally Advanced Gastric Cancer With HER2 Overexpression a Prospective Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 open-label phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery The study drugs include RC48 Adebrelimab Apatinib and S-1 The purpose is to evaluate the effectiveness and safety of the combined coordinated treatment of multi-mechanism drugs for perioperative treatment of locally advanced gastric cancer with HER2 overexpression
Detailed Description:
The study plans to enroll 32 subjects After signing the informed consent form and meeting the inclusion and exclusion criteria patients will receive standard-dose treatment of the RC48 Adebrelimab Apatinib and S-1 regimen for 3-4 cycles every 3 weeks before surgery Apatinib will only be used for 14 days in the last cycle Imaging studies will be conducted 3-4 weeks after the last dose to assess the efficacy of neoadjuvant therapy and the possibility of radical D2 gastrectomy The treatment plan after curative surgery for gastric cancer will be determined by the investigators and the patients based on the pathological findings Patients who benefit clinically after surgery may receive adjuvant therapy with RC48 Adebrelimab Apatinib and S-1 for 4 cycles the first treatment is expected to start around 4 weeks after surgery or follow the standard postoperative adjuvant regimen recommended by the guidelines
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