Ignite Creation Date:
2024-07-17 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468280
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-28
Brief Title:
Synergistic Effects of PD-1 Antibody and Chemotherapy Followed by Surgery in Limited-metastatic GGEJ Adenocarcinoma
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
Synergistic Effects of PD-1 Antibody and Chemotherapy Followed by Surgery in Patients With Limited-metastatic Gastric or Gastroesophageal Adenocarcinoma an Open-label Single-center Randomized Phase 2 Trial ROSETTE Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
ROSETTE
Brief Summary:
The objective of this trial is to compare the efficacy of a comprehensive treatment strategy involving PD-1 monoclonal antibody combined with XELOX chemotherapy followed by radical resection surgery versus simple systemic treatment in patients with limited distant metastasis of gastric adenocarcinomagastroesophageal junction adenocarcinoma
After enrollment and successful screening eligible participants will be randomized in a 11 ratio into a surgical arm and a non-surgical arm and will undergo the following treatment
Surgical Arm
1 Phase 1 Systemic Therapy Administration of PD-1 monoclonal antibody in combination with XELOX chemotherapy for cycles 1-4
2 Surgery Performing a D2 standard gastrectomy for gastric cancer and radical resection of resectable metastatic lesions
3 Phase 2 Systemic Therapy Continuation of PD-1 monoclonal antibody combined with XELOX chemotherapy for cycles 5-8 followed by maintenance therapy with PD-1 monoclonal antibody and capecitabine monotherapy from the 9th cycle until two years post-enrollment
4 During phase 2 systemic therapy concurrent local treatments for unresected metastatic lesions are permitted including radiotherapy interventional embolization radiofrequency ablation and hyperthermic intraperitoneal chemotherapy HIPEC
Non-Surgical Arm
1 Phase 1 Systemic Therapy Administration of PD-1 monoclonal antibody in combination with XELOX chemotherapy for cycles 1-4
2 Phase 2 Systemic Therapy Continuation of PD-1 monoclonal antibody combined with XELOX chemotherapy for cycles 5-8 followed by maintenance therapy with PD-1 monoclonal antibody and capecitabine monotherapy from the 9th cycle until two years post-enrollment
After enrollment and successful screening eligible participants will be randomized in a 11 ratio into a surgical arm and a non-surgical arm and will undergo the following treatment
Surgical Arm
1 Phase 1 Systemic Therapy Administration of PD-1 monoclonal antibody in combination with XELOX chemotherapy for cycles 1-4
2 Surgery Performing a D2 standard gastrectomy for gastric cancer and radical resection of resectable metastatic lesions
3 Phase 2 Systemic Therapy Continuation of PD-1 monoclonal antibody combined with XELOX chemotherapy for cycles 5-8 followed by maintenance therapy with PD-1 monoclonal antibody and capecitabine monotherapy from the 9th cycle until two years post-enrollment
4 During phase 2 systemic therapy concurrent local treatments for unresected metastatic lesions are permitted including radiotherapy interventional embolization radiofrequency ablation and hyperthermic intraperitoneal chemotherapy HIPEC
Non-Surgical Arm
1 Phase 1 Systemic Therapy Administration of PD-1 monoclonal antibody in combination with XELOX chemotherapy for cycles 1-4
2 Phase 2 Systemic Therapy Continuation of PD-1 monoclonal antibody combined with XELOX chemotherapy for cycles 5-8 followed by maintenance therapy with PD-1 monoclonal antibody and capecitabine monotherapy from the 9th cycle until two years post-enrollment
Detailed Description:
None
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