Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341595
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2023-11-14
Brief Title:
Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for GC Patients With PALM
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for Advanced Gastric Cancer Patients With Para-aortic Lymph Node Metastasis a Single-arm Phase II Exploratory Study
Status:
RECRUITING
Status Verified Date:
2024-01
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 trial is a prospective single arm single center phase II clinical study aimed at subjects with advanced gastric cancer and para aortic lymph node metastasis exploring the feasibility and safety of Sintilimab Injection combined with synchronous chemo-radiotherapy as neoadjuvant therapy
Patients will receive sintilimab Injection 200mg iv q3w d1 combined with concurrent radiotherapy and chemotherapy The chemotherapy regimen will use oxaliplatin 130mgm2S-1 40mgm2 bid d1-14 Radiotherapy is performed using intraperitoneal radiation therapy once a day five times a week at a dose of 18-2 Gyf for a total of 45-504 Gy 60-66 Gy for lymph node lesions Radiation therapy starts from the second cycle of Sintilimab Injection combined with chemotherapy The subjects underwent imaging evaluation after completing 4 cycles of combination chemotherapy and radiation therapy with Sintilimab Injection Evaluated as a surgical subject surgical conditions imaging evaluation of enlarged lymph nodes adjacent to the abdominal aorta with PR or no significant activity radical surgery will be performed within 4 weeks after the last study drug treatment After surgery the researcher will determine the necessity of adjuvant treatment and develop an adjuvant treatment plan based on the subjects condition Subjects evaluated as inoperable will have their best follow-up treatment plan determined by the researcher
Patients will receive sintilimab Injection 200mg iv q3w d1 combined with concurrent radiotherapy and chemotherapy The chemotherapy regimen will use oxaliplatin 130mgm2S-1 40mgm2 bid d1-14 Radiotherapy is performed using intraperitoneal radiation therapy once a day five times a week at a dose of 18-2 Gyf for a total of 45-504 Gy 60-66 Gy for lymph node lesions Radiation therapy starts from the second cycle of Sintilimab Injection combined with chemotherapy The subjects underwent imaging evaluation after completing 4 cycles of combination chemotherapy and radiation therapy with Sintilimab Injection Evaluated as a surgical subject surgical conditions imaging evaluation of enlarged lymph nodes adjacent to the abdominal aorta with PR or no significant activity radical surgery will be performed within 4 weeks after the last study drug treatment After surgery the researcher will determine the necessity of adjuvant treatment and develop an adjuvant treatment plan based on the subjects condition Subjects evaluated as inoperable will have their best follow-up treatment plan determined by the researcher
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